Spinal Cord Injury CervicalNCT06773286
Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury
A study testing Active Stimulation and Training only in people with Spinal Cord Injury Cervical, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Active Stimulation and Training only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be at least 18 years of age.
- must have had a spinal cord injury for less than or equal to 8 weeks.
- must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
- must have some degree of motor dysfunction in the hand (bilateral UE motor score <25).
- must be medically stable enough to participate in activity-based recovery training.
- must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
- must have ability to understand and the willingness to sign an informed consent.
Who cannot join
- have a history of seizures, head trauma and/or cognitive deficit
- have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
- have a pressure sore or skin issues.
- have severe spasticity.
- in medically unstable condition.
- have a history of illicit drug abuse.
Show all 11Show fewer
- have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
- unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
- unable to meet the attendance requirements.
- currently enrolled in another interventional research study.
- unable to follow instructions and maintain alertness during assessments and training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Courtney D Bell, 973.965.6629, CBell@kesslerfoundation.org
LeighAnn Martinez, 973.324.3557, LMartinez@kesslerfoundation.org
About this study
Official title: Establishing the Feasibility, Safety, and Efficacy of Spinal Cord Transcutaneous Stimulation with Activity-based Training for Upper Extremity Function Recovery in Individuals with Acute to Subacute Tetraplegia
The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are:
- Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation?
- How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.
Read more
Participants will:
- Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks.
- Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.
Read the detailed description
The objective of this study is to investigate the use of scTS combined with ABT in inpatient rehabilitation, to facilitate UE functional recovery for individuals with acute to subacute cervical SCI. The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention with a 10-day regimen in a randomized, sham-controlled clinical trial. The investigators hypothesize that the combination of scTS+ABT applied in individuals with acute to subacute cervical SCI will 1) be both safe and feasible when implemented as a part of the medical care in an inpatient SCI rehabilitation program, and 2) promote greater improvements in UE function compared to sham control and ABT alone. In addition, the investigators will explore the potential neurophysiological mechanism underlying the combined intervention by evaluating the pre-post changes of cortical and spinal excitability. The investigators anticipate that the functional outcome improvements will be associated with the gains of cortical and spinal excitability.
(Aim 1) To determine whether scTS+ABT intervention is safe when applied to persons with acute to subacute cervical SCI during inpatient rehabilitation. The investigators will evaluate the intervention safety based on the adverse event reports focusing three categories: (1) scTS-related (pain/discomfort and skin integrity), (2) ABT-related (musculoskeletal injuries, heart rate, and oxygen saturation levels), and (3) SCI-related (spasticity and autonomic dysreflexia). The type, frequency, and severity of adverse events reported in scTS+ABT group will be compared to those from ABT alone group. (Aim 2) To examine whether a 10-day regimen of scTS+ABT is feasible to apply to individuals with acute to subacute SCI during an inpatient rehabilitation program. The interest and willingness of participants to enroll and complete this study will provide insight into the feasibility of scTS+ABT intervention. The investigators will assess the feasibility based on quantitative data including ease of recruitment (accrual rate) and study completion rate and compare the study completion rate in scTS+ABT and ABT alone group. (Aim 3) To evaluate the efficacy of scTS+ABT intervention in promoting UE functional recovery in acute to subacute SCI, as compared to the sham control and ABT only. Given the greatest opportunity for recovery and neuroplasticity in acute-subacute SCI stage and the promising results demonstrated in the previous chronic SCI studies, the investigators expect that applying scTS+ABT at early stages would lead to greater UE function improvements compared to scTSsham+ABT and ABT only. UE motor impairment, voluntary handgrip strength, and UE functional ability will be quantitatively assessed three time at baseline, once at the end of intervention, and once at 1-, 2-, 3-month follow up. Within-group and between-group comparison will be made to evaluate the efficacy of different interventions. (Aim 4, Exploratory) To quantify and characterize the neurophysiological changes after scTS+ABT, as compared to the sham control or ABT alone. Previous chronic studies have suggested that scTS can increase the excitability of spinal network and activate the motor neurons within spinal cord distal to the lesion, leading to restoration of voluntary motor control. Here, the investigators will examine whether a 10-day regimen of scTS+ABT applied in the acute to subacute stage can also lead to neurophysiological gains. Pre-post changes in the cortical and spinal excitability will be measured and compared to the sham control and ABT only group. As an exploratory aim, the investigators will evaluated on a subset sample of each group (n=4).
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Active Stimulation, Sham, Training only
- Keywords
- Spinal Cord Injury, Inpatient Rehabilitation, Upper Extremity, Spinal Cord Transcutaneous Stimulation, Activity-based Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StimulationOther
Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
ShamOther
The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Training onlyOther
articipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.
| Study group | Role | What they receive |
|---|---|---|
| Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training | Active comparator | Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. Receives: Other: Active Stimulation |
| Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training | Sham comparator | The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. Receives: Other: Sham |
| Activity-based Training Only | Other | Participants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side. Receives: Other: Training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain before and after daily intervention
Subjects will be asked to rate their pain intensity using an 11-point Numerical Rating Scale (i.e. 0-10), before and after each intervention session. The change in pain will be documented.
Measured: From the beginning to the end of each intervention session at 30 minutes
Change of skin integrity before and after daily intervention session
Skin integrity under electrode placement site will be assessed by a clinician before and after each session, any change i.e., redness, swelling, breakdown, will be recorded.
Measured: From the beginning to the end of each intervention session at 30 minutes
Study completion rate
Study completion rate will be calculated at post-intervention by dividing the number of participants who will be present at these time points by the number of individuals who are enrolled and begin the intervention.
Measured: From enrollment to the post-intervention assessment at 3 weeks
Secondary outcomes (4)
Adverse event after daily intervention session
An adverse events survey will be completed on a daily basis to evaluate adverse effects potentially related to spinal stimulation, activity-based training, and SCI.
Measured: At the end of each intervention session at 30 minutes
Change of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Scores
GRASSP is a standard clinical outcome measure used to evaluate the hand and UE function in people with cervical SCI. Specifically, this outcome measure evaluates UE strength, sensation, the ability to complete different grasp patterns, and the ability to utilize those grasp patterns to successfully complete functional activities. It consists of four subtests for each upper limb: dorsal and palmar sensation, strength (tested with motor grading of 10 muscles), and prehension (distinguishes scores for qualitative and quantitative grasping). The numerical scores in each subtest provide a comprehensive assessment of UE function.
Measured: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Change of voluntary handgrip forces
Maximum voluntary handgrip forces will be measured from both hands by using a hand-held dynamometer (Echo, JTECH Medical, Midvale, Utah) with stimulation turned off. To avoid compensation movement (tenodesis), testing will be performed in a standardized way with participants seated upright, shoulder adducted and neutrally rotated, elbow flexed 90 degrees, and forearm in the neutral position. A total of three trials will be assessed on each side, with a rest break between trials. The average of three maximal force measurements per trial will be reported.
Measured: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Change of the Capabilities of Upper Extremity Test (CUE-T) Scores
The Capabilities of Upper Extremity Test (CUE-T) will be used to evaluate the functional abilities, including 19 tasks (17 unilateral and 2 bilateral). Tasks involve a range of UE movements performed across proximal and distal joints for assessment of gross and fine motor function. Scoring for each item is based on ability to complete, rate of movement and time taken.
Measured: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start8 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Zhang, Kessler Foundation
- Investigators
- Gail Forrest, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773286
- Sponsor's protocol ID
- 40652
- Other IDs
- CSCR23ERG001
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Freitas RM, Sasaki A, Sayenko DG, Masugi Y, Nomura T, Nakazawa K, Milosevic M. Selectivity and excitability of upper-limb muscle activation during cervical transcutaneous spinal cord stimulation in humans. J Appl Physiol (1985). 2021 Aug 1;131(2):746-759. doi: 10.1152/japplphysiol.00132.2021. Epub 2021 Jun 17.
PubMed 34138648Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
PubMed 26077679Popovic MR, Kapadia N, Zivanovic V, Furlan JC, Craven BC, McGillivray C. Functional electrical stimulation therapy of voluntary grasping versus only conventional rehabilitation for patients with subacute incomplete tetraplegia: a randomized clinical trial. Neurorehabil Neural Repair. 2011 Jun;25(5):433-42. doi: 10.1177/1545968310392924. Epub 2011 Feb 8.
PubMed 21304020Kloosterman MG, Snoek GJ, Jannink MJ. Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. Spinal Cord. 2009 Mar;47(3):196-203. doi: 10.1038/sc.2008.113. Epub 2008 Sep 30.
PubMed 18825160Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
PubMed 29164023Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.
PubMed 15224087Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.
PubMed 33382659Freyvert Y, Yong NA, Morikawa E, Zdunowski S, Sarino ME, Gerasimenko Y, Edgerton VR, Lu DC. Engaging cervical spinal circuitry with non-invasive spinal stimulation and buspirone to restore hand function in chronic motor complete patients. Sci Rep. 2018 Oct 19;8(1):15546. doi: 10.1038/s41598-018-33123-5.
PubMed 30341390Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.
PubMed 29649928Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
PubMed 29877852
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Feasibility, Safety, and Efficacy of Spinal Cord Transcutaneous Stimulation with Activity-based Training for Upper Extremity Function Recovery in Individuals with Acute to Subacute Tetraplegia
- ClinicalTrials.gov ID
- NCT06773286
- Acronym / sponsor ID
- 40652
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Spinal Cord Injury, Inpatient Rehabilitation, Upper Extremity, Spinal Cord Transcutaneous Stimulation, Activity-based Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are:
- Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation?
- How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.
Participants will:
- Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks.
- Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.
Detailed description
The objective of this study is to investigate the use of scTS combined with ABT in inpatient rehabilitation, to facilitate UE functional recovery for individuals with acute to subacute cervical SCI. The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention with a 10-day regimen in a randomized, sham-controlled clinical trial. The investigators hypothesize that the combination of scTS+ABT applied in individuals with acute to subacute cervical SCI will 1) be both safe and feasible when implemented as a part of the medical care in an inpatient SCI rehabilitation program, and 2) promote greater improvements in UE function compared to sham control and ABT alone. In addition, the investigators will explore the potential neurophysiological mechanism underlying the combined intervention by evaluating the pre-post changes of cortical and spinal excitability. The investigators anticipate that the functional outcome improvements will be associated with the gains of cortical and spinal excitability.
(Aim 1) To determine whether scTS+ABT intervention is safe when applied to persons with acute to subacute cervical SCI during inpatient rehabilitation. The investigators will evaluate the intervention safety based on the adverse event reports focusing three categories: (1) scTS-related (pain/discomfort and skin integrity), (2) ABT-related (musculoskeletal injuries, heart rate, and oxygen saturation levels), and (3) SCI-related (spasticity and autonomic dysreflexia). The type, frequency, and severity of adverse events reported in scTS+ABT group will be compared to those from ABT alone group. (Aim 2) To examine whether a 10-day regimen of scTS+ABT is feasible to apply to individuals with acute to subacute SCI during an inpatient rehabilitation program. The interest and willingness of participants to enroll and complete this study will provide insight into the feasibility of scTS+ABT intervention. The investigators will assess the feasibility based on quantitative data including ease of recruitment (accrual rate) and study completion rate and compare the study completion rate in scTS+ABT and ABT alone group. (Aim 3) To evaluate the efficacy of scTS+ABT intervention in promoting UE functional recovery in acute to subacute SCI, as compared to the sham control and ABT only. Given the greatest opportunity for recovery and neuroplasticity in acute-subacute SCI stage and the promising results demonstrated in the previous chronic SCI studies, the investigators expect that applying scTS+ABT at early stages would lead to greater UE function improvements compared to scTSsham+ABT and ABT only. UE motor impairment, voluntary handgrip strength, and UE functional ability will be quantitatively assessed three time at baseline, once at the end of intervention, and once at 1-, 2-, 3-month follow up. Within-group and between-group comparison will be made to evaluate the efficacy of different interventions. (Aim 4, Exploratory) To quantify and characterize the neurophysiological changes after scTS+ABT, as compared to the sham control or ABT alone. Previous chronic studies have suggested that scTS can increase the excitability of spinal network and activate the motor neurons within spinal cord distal to the lesion, leading to restoration of voluntary motor control. Here, the investigators will examine whether a 10-day regimen of scTS+ABT applied in the acute to subacute stage can also lead to neurophysiological gains. Pre-post changes in the cortical and spinal excitability will be measured and compared to the sham control and ABT only group. As an exploratory aim, the investigators will evaluated on a subset sample of each group (n=4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training | Active comparator | Other: Active StimulationParticipants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. |
| Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training | Sham comparator | Other: ShamThe sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. |
| Activity-based Training Only | Other | Other: Training onlyParticipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- must be at least 18 years of age.
- must have had a spinal cord injury for less than or equal to 8 weeks.
- must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
- must have some degree of motor dysfunction in the hand (bilateral UE motor score <25).
- must be medically stable enough to participate in activity-based recovery training.
Key exclusion criteria (11 listed)
- have a history of seizures, head trauma and/or cognitive deficit
- have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
- have a pressure sore or skin issues.
- have severe spasticity.
- in medically unstable condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active StimulationParticipants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. | Other | Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training |
| ShamThe sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy. | Other | Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training |
| Training onlyarticipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side. | Other | Activity-based Training Only |
Primary outcome
Change of pain before and after daily intervention
Time frame: From the beginning to the end of each intervention session at 30 minutes
Subjects will be asked to rate their pain intensity using an 11-point Numerical Rating Scale (i.e. 0-10), before and after each intervention session. The change in pain will be documented.
Change of skin integrity before and after daily intervention session
Time frame: From the beginning to the end of each intervention session at 30 minutes
Skin integrity under electrode placement site will be assessed by a clinician before and after each session, any change i.e., redness, swelling, breakdown, will be recorded.
Study completion rate
Time frame: From enrollment to the post-intervention assessment at 3 weeks
Study completion rate will be calculated at post-intervention by dividing the number of participants who will be present at these time points by the number of individuals who are enrolled and begin the intervention.
4 secondary outcomes
Adverse event after daily intervention session
Time frame: At the end of each intervention session at 30 minutes
Change of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Scores
Time frame: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Change of voluntary handgrip forces
Time frame: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Change of the Capabilities of Upper Extremity Test (CUE-T) Scores
Time frame: From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 34138648de Freitas RM, Sasaki A, Sayenko DG, Masugi Y, Nomura T, Nakazawa K, Milosevic M. Selectivity and excitability of upper-limb muscle activation during cervical transcutaneous spinal cord stimulation in humans. J Appl Physiol (1985). 2021 Aug 1;131(2):746-759. doi: 10.1152/japplphysiol.00132.2021. Epub 2021 Jun 17.
- Background: PubMed 26077679Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
- Background: PubMed 21304020Popovic MR, Kapadia N, Zivanovic V, Furlan JC, Craven BC, McGillivray C. Functional electrical stimulation therapy of voluntary grasping versus only conventional rehabilitation for patients with subacute incomplete tetraplegia: a randomized clinical trial. Neurorehabil Neural Repair. 2011 Jun;25(5):433-42. doi: 10.1177/1545968310392924. Epub 2011 Feb 8.
- Background: PubMed 18825160Kloosterman MG, Snoek GJ, Jannink MJ. Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. Spinal Cord. 2009 Mar;47(3):196-203. doi: 10.1038/sc.2008.113. Epub 2008 Sep 30.
- Background: PubMed 29164023Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
- Background: PubMed 15224087Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.
- Background: PubMed 33382659Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.
- Background: PubMed 30341390Freyvert Y, Yong NA, Morikawa E, Zdunowski S, Sarino ME, Gerasimenko Y, Edgerton VR, Lu DC. Engaging cervical spinal circuitry with non-invasive spinal stimulation and buspirone to restore hand function in chronic motor complete patients. Sci Rep. 2018 Oct 19;8(1):15546. doi: 10.1038/s41598-018-33123-5.
- Background: PubMed 29649928Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.
- Background: PubMed 29877852Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gail Forrest, PhD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Stimulation and Training only in people with Spinal Cord Injury Cervical, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan Zhang, PhD (4015362070, fzhang@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain before and after daily intervention (time frame: From the beginning to the end of each intervention session at 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06773286, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.