Spinal Cord InjuryNCT07433959
Neuromodulation to Improve Grasping Function After SCI
A study testing iTBS, PCMS and Exercise in people with Spinal Cord Injury, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- iTBS, PCMS and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Jun 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For individuals with SCI:
- Ages 18-75 years
- Chronic SCI (≥1 year of injury)
- Cervical injury at C8 or above
- Individuals who have MEP responses in at least one FDI muscle
Who cannot join
- Uncontrolled medical problems including pulmonary or cardiovascular disease
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
- Pregnant females
- Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical
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
The State University of New York at Buffalo
Buffalo, New York, 14214
Karen Barnes, 716-829-6718, barneska@buffalo.edu
About this study
Official title: Neuromodulation to Improve Grasping Function After Spinal Cord Injury
The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.
Read the detailed description
The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- iTBS, Sham iTBS, PCMS, Sham PCMS, Exercise
- 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.
iTBSOther
Intermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses in 190 seconds).
Sham iTBSOther
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
PCMSOther
During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.
Sham PCMSOther
During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.
ExerciseBehavioural
The motor training will be focused on participant's hand motor function such as grasping function.
| Study group | Role | What they receive |
|---|---|---|
| iTBS and PCMS | Active comparator | iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention. Receives: Other: iTBS; Other: PCMS |
| Sham iTBS and PCMS | Sham comparator | Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention. Receives: Other: Sham iTBS; Other: PCMS |
| iTBS and PCMS with exercise | Active comparator | Participants will complete iTBS and PCMS with exercise for 10 sessions. Receives: Other: iTBS; Other: PCMS; Behavioral: Exercise |
| Sham iTBS and sham PCMS with exercise | Sham comparator | Participants will complete sham stimulation with exercise for 10 sessions. Receives: Other: Sham iTBS; Other: Sham PCMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP)
Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.
Measured: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Secondary outcomes (3)
Maximum voluntary contraction (MVC)
Individuals will perform a MVC of the targeted hand muscle (first dorsal interosseous) through surface EMG electrodes. The investigators will collect two MVC trials and use the average of the two.
Measured: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Grip force
Grip force will be assessed with hand grip dynamometer. The highest value of the three trials will be used.
Measured: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)
TRI-HFT is clinical assessment tool to measure specifically unilateral pinch and grasp hand function.
Measured: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Crossover
- Model description
- The first part of the study utilizes a crossover design, while the second part utilizes a parallel design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hang Jin Jo, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433959
- Sponsor's protocol ID
- STUDY00009877
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation to Improve Grasping Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07433959
- Acronym / sponsor ID
- STUDY00009877
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Feb 2026 (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 goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.
Detailed description
The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The first part of the study utilizes a crossover design, while the second part utilizes a parallel design.
| Arm | Type | Receives |
|---|---|---|
| iTBS and PCMS | Active comparator | Other: iTBS, Other: PCMSiTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention. |
| Sham iTBS and PCMS | Sham comparator | Other: Sham iTBS, Other: PCMSSham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention. |
| iTBS and PCMS with exercise | Active comparator | Other: iTBS, Other: PCMS, Behavioral: ExerciseParticipants will complete iTBS and PCMS with exercise for 10 sessions. |
| Sham iTBS and sham PCMS with exercise | Sham comparator | Other: Sham iTBS, Other: Sham PCMSParticipants will complete sham stimulation with exercise for 10 sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-75 years
- Chronic SCI (≥1 year of injury)
- Cervical injury at C8 or above
- Individuals who have MEP responses in at least one FDI muscle
Key exclusion criteria (8 listed)
- Uncontrolled medical problems including pulmonary or cardiovascular disease
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Metal plate in skull
- History of seizures
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 |
|---|---|---|
| iTBSIntermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses in 190 seconds). | Other | iTBS and PCMS, iTBS and PCMS with exercise |
| Sham iTBSSham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used. | Other | Sham iTBS and PCMS, Sham iTBS and sham PCMS with exercise |
| PCMSDuring PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission. | Other | Sham iTBS and PCMS, iTBS and PCMS, iTBS and PCMS with exercise |
| Sham PCMSDuring PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity. | Other | Sham iTBS and sham PCMS with exercise |
| ExerciseThe motor training will be focused on participant's hand motor function such as grasping function. | Behavioural | iTBS and PCMS with exercise |
Primary outcome
Motor evoked potential (MEP)
Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.
3 secondary outcomes
Maximum voluntary contraction (MVC)
Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Grip force
Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)
Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
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 23 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS, PCMS and Exercise in people with Spinal Cord Injury, run by State University of New York at Buffalo 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 5 inclusion and 8 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 23 Apr 2026. 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 Hang Jin Jo, PhD (716-829-2905, hangjinj@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potential (MEP) (time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.