Spinal Cord InjuriesDS-SCINCT07467850

Dual Stimulation for Spinal Cord Injury

A study testing tsDCS+pDCS and Low-level laser therapy in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries
What is being tested?: tsDCS+pDCS and Low-level laser therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2022to 1 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women aged 18 or older with traumatic SCI (ASIA A-B).
The injury has less than six months of evolution.
Patients admitted to the Spaulding SCI Rehabilitation Unit at Spaulding Rehabilitation Hospital.
Respiratory and hemodynamically stable.

Who cannot join

They have any contraindications for receiving tsDCS, such as skin wounds in the place of application.
Any known hypersensitivity to light therapy
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding
Current use of a ventilator
Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study
Pregnancy or breastfeeding. People with childbearing capacity who are eligible to participate in the study will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129

Other trials in United States

About this study

The goal of this Spinal Cord Injury (SCI) Open-Label Clinical Trial is to test the safety and feasibility of the intervention. The study aims to answer whether implementing this intervention on inpatients at a specialized rehabilitation hospital is possible. All participants will receive the intervention and be asked to report side effects and tolerability. Additionally, injury markers for safety and signal recordings to detect changes will be assessed pre- and post-intervention.

Read the detailed description

This proposal seeks to apply non-invasive technology for hyperexcitability suppression, decrease inflammation, and promote restorative processes along the neural axis and the brain in patients with complete SCI in a highly innovative treatment paradigm with the potential for large-scale clinical impact.

This project will be the first to examine the proposed treatment approach in subacute inpatients with complete SCI. This will be a pilot open-label study using historical controls from the Spinal Cord Injury Model Data Center. A follow-up period (3- and 6-month post-intervention) will be required to evaluate the progression of these patients. The investigators aim to recruit eight patients based on historical admissions data from our institution.

Specific aims for this project are:

Aim 1: To assess safety and feasibility. Investigators will begin subject enrollment from the SCI inpatient unit at Spaulding Rehabilitation Hospital. The investigators will explore the effects of non-invasive neuromodulation + photobiomodulation among hospitalized American Spinal Cord Injury Association (ASIA) A/B patients (i.e., through analysis of enrollment, treatment tolerability, retention, medication use, and adverse effects).

Aim 2: To explore neurophysiological and clinical markers associated with recovery in SCI.

The investigators will evaluate inpatient evolution by measuring standard clinical assessments of sensorimotor function, the visual analog scale (VAS) for pain, the SCI pain interference scale, the modified Ashworth scale (MAS) for spasticity, and the Spinal Cord Injury - Quality of Life measurement system SCI-QOL. Neurophysiological markers will include surface electromyography (sEMG) to evaluate biological markers of corticospinal activity and sympathetic skin responses (SSR) to assess sudomotor function.

Aim 3: To explore mental health and cognitive function in this group of patients and assess this therapeutical approach's impact.

Hypothesis

Concerning Aim 1, The hypothesis is that the intervention and research procedures will be feasible and safe as evidenced by successful recruitment, screening, eligibility, enrollment rates, tolerability, low or mild adverse events, and no increased levels of specific enolase after the intervention.

The hypothesis for Aim 2 is that neurophysiological measurement will be feasible to collect and use as evidenced by tolerability to the procedures, quality, and reliability of the recorded signals, and viability and accuracy of the processing and analyses.

In the Aim 3 hypothesis, investigators can assess mental health and cognitive function successfully in this group of patients. The data from measures collected in this study will identify patterns across the time points, providing information for designing a future efficacy trial.

Conditions: Spinal Cord Injuries
Being tested: tsDCS+pDCS, Low-level laser therapy
Keywords: sci, trans-spinal electrical stimulation, photobiomodulation
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.

tsDCS+pDCSDevice
Also called MyoRegulator, trans-spinal and peripheral direct current stimulation
Pathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation.
Low-level laser therapyDevice
Also called photobiomodulation, LLLT, FX405, cold laser
Erchonia Corp. "Erchonia FX405" low level laser

Study groups in NCT07467850
Study group	Role	What they receive
Non-invasive dual electrical neuromodulation and photobiomodulation	Experimental	Trans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS) Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions AND Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode Receives: Device: tsDCS+pDCS; Device: Low-level laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Device Feasibility (functionality of the prototype device)
Device feasibility will be evaluated by device operability throughout the intervention period, these measurements will include; skin bioimpedance (Ohms), ramping up and down of electrical current in mA, and voltage stability during the stimulation (mA) period.
Skin bioimpedance, ramping, and voltage stability will be combined to report device functionality represented as optimal stimulation or non-optimal.
Measured: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.
Intervention safety through adverse events analysis as measured by the Common Terminology Criteria for Adverse Events (CTCAE)
Number of Participants presenting Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.

Secondary outcomes (11)

The American Spinal Cord Injury Association test (ASIA)
It's a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment. It involves a Motor and Sensory examination to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI), and whether the injury is Complete or Incomplete. ASIA is a standardized examination consisting of a myotonic-based motor examination, a dermatomal-based sensory examination, and an anorectal examination. Based on the findings of these examinations, injury severity or grade and level are assigned.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. They are generally completed by patients but are sometimes used to elicit opinions from health professionals.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Reflex recovery
Reflexes assessed by the treating physician during physical examination by exploring the extremities affected by the site of injury.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Spinal Cord Injury - Functional Index (SCI-FI)
SCI-FI is a system of patient-reported outcome measures of functional activities developed specifically with and for individuals with spinal cord injury (SCI). It consists of 9-item response theory-calibrated item banks that represent relevant and meaningful item content for individuals with SCI, span a wide range of functional abilities, and subdivide physical functioning into important subdomains, including essential mobility, self-care, and fine motor function. The SCI-FI measures five subdomains; the investigators will include three subdomains of physical function: virtual mobility, self-care, and ambulation in a conceptual structure unique to individuals with SCI.
Measured: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.
The modified Ashworth scale (MAS)
MAS is a six-category ordinal scale used to assess the resistance encountered during passive muscle stretching that does not require instrumentation and is quick to perform. The MAS is the current standard for clinical assessment of lower extremity spasticity and the most commonly used tool to evaluate the efficacy of pharmacologic and rehabilitation interventions for treating spasticity among patients with SCI. The MAS is the gold standard against which new assessment tools are evaluated.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Spinal Cord Injury - Quality of Life (SCI-QOL)
SCI-QOL is a measurement system that was developed to address the shortage of relevant and psychometrically sound patient-reported outcome (PRO) measures available for clinical care and research in (SCI) rehabilitation. It consists of 19 item banks, including the SCI-Functional Index banks, and three fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL)
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG)
The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG) is a brief, portable and easy-to-administer cognitive screening instrument developed at the Neuropsychiatry Unit of the Royal Melbourne Hospital, Australia, for use in psychiatric and neurologic patient populations, with an emphasis on balancing breadth and brevity, while ensuring sensitivity to the subtle changes seen across a range of disorders. It consists of 21 items that assess cognitive function across five cognitive functional domains: attention, memory, executive, visuo-constructional, and language, and is based on established cognitive tests, with items similar to those found in other cognitive screening tools. It has been designed to be administered in approximately 20 to 30 minutes. The NUCOG provides a total score of 100, with each of the five domains having a total score of 20.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
High-density surface electromyography (HD-sEMG)
High-density surface electromyography (HD-sEMG): is a non-invasive technique to measure electrical muscle activity with multiple (more than two) closely spaced electrodes overlying a restricted skin area. It is a method for recording Motor Unit Action Potentials (MUAP) over a muscle, using 2D arrays of closely spaced electrodes. Unlike traditional surface electromyography (sEMG), it accounts for both the signal's spatial and temporal characteristics, allowing a broader assessment of muscle electrophysiological activity.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Sympathetic skin responses (SSRs)
SSR is a convenient, non-invasive measure of autonomic function in various conditions, including SCI. It represents one of many techniques available to directly or indirectly measure sympathetic outflow to the skin. A measure of sympathetic cholinergic sudomotor function has been used to assess autonomic dysfunction in patients with spinal cord injury (SCI). It can be a useful surrogate measure of global autonomic function in research and as a diagnostic tool.
Measured: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Skin surveillance
The investigators will record skin pictures before and after each intervention to document safety, the investigators will only include the site where the electrodes are placed (wrist, neck, and abdomen), and the investigators won't have any identifiable features of the subject, like face, birthmarks, or tattoos. The investigators will get consent to perform this and provide a written agreement document to sign at the beginning of the study.
Measured: Baseline at day 0; during intervention (10 days) and post-intervention after 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 20221 Sep 2024

First posted12 Mar 2026
Study start14 Jul 2022
Primary completion1 Jul 2024
Study completion1 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (63)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies 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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07467850
Sponsor's protocol ID: 2022P001088
Acronym: DS-SCI
Status last verified: Mar 2026
First submitted: 27 Oct 2022
Last updated: 12 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine (Phila Pa 1976). 2001 Dec 15;26(24 Suppl):S2-12. doi: 10.1097/00007632-200112151-00002.
PubMed 11805601
Mirovsky Y, Shalmon E, Blankstein A, Halperin N. Complete paraplegia following gunshot injury without direct trauma to the cord. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2436-8. doi: 10.1097/01.brs.0000184588.54710.61.
PubMed 16261122
Ambrozaitis KV, Kontautas E, Spakauskas B, Vaitkaitis D. [Pathophysiology of acute spinal cord injury]. Medicina (Kaunas). 2006;42(3):255-61. Lithuanian.
PubMed 16607070
Janssen L, Hansebout RR. Pathogenesis of spinal cord injury and newer treatments. A review. Spine (Phila Pa 1976). 1989 Jan;14(1):23-32. doi: 10.1097/00007632-198901000-00005.
PubMed 2536508
Fehlings MG, Perrin RG. The role and timing of early decompression for cervical spinal cord injury: update with a review of recent clinical evidence. Injury. 2005 Jul;36 Suppl 2:B13-26. doi: 10.1016/j.injury.2005.06.011.
PubMed 15993113
Lewin MG, Hansebout RR, Pappius HM. Chemical characteristics of traumatic spinal cord edema in cats. Effects of steroids on potassium depletion. J Neurosurg. 1974 Jan;40(1):65-75. doi: 10.3171/jns.1974.40.1.0065. No abstract available.
PubMed 4808487
Oyinbo CA. Secondary injury mechanisms in traumatic spinal cord injury: a nugget of this multiply cascade. Acta Neurobiol Exp (Wars). 2011;71(2):281-99. doi: 10.55782/ane-2011-1848.
PubMed 21731081
von Leden RE, Yauger YJ, Khayrullina G, Byrnes KR. Central Nervous System Injury and Nicotinamide Adenine Dinucleotide Phosphate Oxidase: Oxidative Stress and Therapeutic Targets. J Neurotrauma. 2017 Feb 15;34(4):755-764. doi: 10.1089/neu.2016.4486. Epub 2016 Jun 27.
PubMed 27267366
Tran AP, Warren PM, Silver J. The Biology of Regeneration Failure and Success After Spinal Cord Injury. Physiol Rev. 2018 Apr 1;98(2):881-917. doi: 10.1152/physrev.00017.2017.
PubMed 29513146
Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Myelin damage and repair in pathologic CNS: challenges and prospects. Front Mol Neurosci. 2015 Jul 27;8:35. doi: 10.3389/fnmol.2015.00035. eCollection 2015.
PubMed 26283909
Wijesuriya N, Tran Y, Middleton J, Craig A. Impact of fatigue on the health-related quality of life in persons with spinal cord injury. Arch Phys Med Rehabil. 2012 Feb;93(2):319-24. doi: 10.1016/j.apmr.2011.09.008.
PubMed 22289244
Richards JS, Brown L, Hagglund K, Bua G, Reeder K. Spinal cord injury and concomitant traumatic brain injury. Results of a longitudinal investigation. Am J Phys Med Rehabil. 1988 Oct;67(5):211-6. doi: 10.1097/00002060-198810000-00005.
PubMed 3179011
Tolonen A, Turkka J, Salonen O, Ahoniemi E, Alaranta H. Traumatic brain injury is under-diagnosed in patients with spinal cord injury. J Rehabil Med. 2007 Oct;39(8):622-6. doi: 10.2340/16501977-0101.
PubMed 17896053
Dowler RN, Harrington DL, Haaland KY, Swanda RM, Fee F, Fiedler K. Profiles of cognitive functioning in chronic spinal cord injury and the role of moderating variables. J Int Neuropsychol Soc. 1997 Sep;3(5):464-72.
PubMed 9322406
Craig A, Guest R, Tran Y, Middleton J. Cognitive Impairment and Mood States after Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1156-1163. doi: 10.1089/neu.2016.4632. Epub 2016 Nov 2.
PubMed 27717295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dual Stimulation for Spinal Cord Injury
ClinicalTrials.gov ID: NCT07467850
Acronym / sponsor ID: DS-SCI / 2022P001088
Conditions: Spinal Cord Injuries
Keywords: sci, trans-spinal electrical stimulation, photobiomodulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Collaborators: PathMaker Neurosystems Inc., Erchonia Corporation
Study start: 14 Jul 2022 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 1 Sep 2024 (actual)
First posted: 12 Mar 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.

Detailed description

Specific aims for this project are:

Aim 2: To explore neurophysiological and clinical markers associated with recovery in SCI.

Aim 3: To explore mental health and cognitive function in this group of patients and assess this therapeutical approach's impact.

Hypothesis

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non-invasive dual electrical neuromodulation and photobiomodulation	Experimental	Device: tsDCS+pDCS, Device: Low-level laser therapyTrans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS) Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions AND Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women aged 18 or older with traumatic SCI (ASIA A-B).
The injury has less than six months of evolution.
Patients admitted to the Spaulding SCI Rehabilitation Unit at Spaulding Rehabilitation Hospital.
Respiratory and hemodynamically stable.

Key exclusion criteria (6 listed)

They have any contraindications for receiving tsDCS, such as skin wounds in the place of application.
Any known hypersensitivity to light therapy
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding
Current use of a ventilator
Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study

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
tsDCS+pDCSAlso: MyoRegulator, trans-spinal and peripheral direct current stimulationPathmaker Neurosystems Inc. "MyoRegulator" trans-spinal and peripheral direct current stimulation.	Device	Non-invasive dual electrical neuromodulation and photobiomodulation
Low-level laser therapyAlso: photobiomodulation, LLLT, FX405, cold laserErchonia Corp. "Erchonia FX405" low level laser	Device	Non-invasive dual electrical neuromodulation and photobiomodulation

Primary outcome

Device Feasibility (functionality of the prototype device)
Time frame: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.
Device feasibility will be evaluated by device operability throughout the intervention period, these measurements will include; skin bioimpedance (Ohms), ramping up and down of electrical current in mA, and voltage stability during the stimulation (mA) period. Skin bioimpedance, ramping, and voltage stability will be combined to report device functionality represented as optimal stimulation or non-optimal.
Intervention safety through adverse events analysis as measured by the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Number of Participants presenting Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

11 secondary outcomes

The American Spinal Cord Injury Association test (ASIA)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Visual Analogue Scale (VAS)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Reflex recovery
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Spinal Cord Injury - Functional Index (SCI-FI)
Time frame: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.
The modified Ashworth scale (MAS)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Spinal Cord Injury - Quality of Life (SCI-QOL)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
High-density surface electromyography (HD-sEMG)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Sympathetic skin responses (SSRs)
Time frame: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Skin surveillance
Time frame: Baseline at day 0; during intervention (10 days) and post-intervention after 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Background: PubMed 11805601Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine (Phila Pa 1976). 2001 Dec 15;26(24 Suppl):S2-12. doi: 10.1097/00007632-200112151-00002.
Background: PubMed 16261122Mirovsky Y, Shalmon E, Blankstein A, Halperin N. Complete paraplegia following gunshot injury without direct trauma to the cord. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2436-8. doi: 10.1097/01.brs.0000184588.54710.61.
Background: PubMed 16607070Ambrozaitis KV, Kontautas E, Spakauskas B, Vaitkaitis D. [Pathophysiology of acute spinal cord injury]. Medicina (Kaunas). 2006;42(3):255-61. Lithuanian.
Background: PubMed 2536508Janssen L, Hansebout RR. Pathogenesis of spinal cord injury and newer treatments. A review. Spine (Phila Pa 1976). 1989 Jan;14(1):23-32. doi: 10.1097/00007632-198901000-00005.
Background: PubMed 15993113Fehlings MG, Perrin RG. The role and timing of early decompression for cervical spinal cord injury: update with a review of recent clinical evidence. Injury. 2005 Jul;36 Suppl 2:B13-26. doi: 10.1016/j.injury.2005.06.011.
Background: PubMed 4808487Lewin MG, Hansebout RR, Pappius HM. Chemical characteristics of traumatic spinal cord edema in cats. Effects of steroids on potassium depletion. J Neurosurg. 1974 Jan;40(1):65-75. doi: 10.3171/jns.1974.40.1.0065. No abstract available.
Background: PubMed 21731081Oyinbo CA. Secondary injury mechanisms in traumatic spinal cord injury: a nugget of this multiply cascade. Acta Neurobiol Exp (Wars). 2011;71(2):281-99. doi: 10.55782/ane-2011-1848.
Background: PubMed 27267366von Leden RE, Yauger YJ, Khayrullina G, Byrnes KR. Central Nervous System Injury and Nicotinamide Adenine Dinucleotide Phosphate Oxidase: Oxidative Stress and Therapeutic Targets. J Neurotrauma. 2017 Feb 15;34(4):755-764. doi: 10.1089/neu.2016.4486. Epub 2016 Jun 27.
Background: PubMed 29513146Tran AP, Warren PM, Silver J. The Biology of Regeneration Failure and Success After Spinal Cord Injury. Physiol Rev. 2018 Apr 1;98(2):881-917. doi: 10.1152/physrev.00017.2017.
Background: PubMed 26283909Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Myelin damage and repair in pathologic CNS: challenges and prospects. Front Mol Neurosci. 2015 Jul 27;8:35. doi: 10.3389/fnmol.2015.00035. eCollection 2015.
Background: PubMed 22289244Wijesuriya N, Tran Y, Middleton J, Craig A. Impact of fatigue on the health-related quality of life in persons with spinal cord injury. Arch Phys Med Rehabil. 2012 Feb;93(2):319-24. doi: 10.1016/j.apmr.2011.09.008.
Background: PubMed 3179011Richards JS, Brown L, Hagglund K, Bua G, Reeder K. Spinal cord injury and concomitant traumatic brain injury. Results of a longitudinal investigation. Am J Phys Med Rehabil. 1988 Oct;67(5):211-6. doi: 10.1097/00002060-198810000-00005.
Individual participant dataSharing planned: No

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Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tsDCS+pDCS and Low-level laser therapy in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Feasibility (functionality of the prototype device) (time frame: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.). The study lists 2 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 NCT07467850, which also lists 63 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 12 Mar 2026.