Spinal Cord InjuryNCT06815601
Neuromodulation After Spinal Cord Injury to Improve Limb Function
A study testing rTMS and Motor training in people with Spinal Cord Injury and Spinal Cord Injury Cervical, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. 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, Spinal Cord Injury Cervical
- What is being tested?
- rTMS and Motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy adults between the ages of 18-75 years old who are right-handed
- Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)
Who cannot join
- For both healthy individuals and those with SCI:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Ongoing major depression or altered cognitive status
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Kimball Tower at The State University of New York at Buffalo
Buffalo, New York, 14214
About this study
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.
Read the detailed description
The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Cervical
- Being tested
- rTMS, Sham rTMS, Motor training
- Keywords
- spinal cord injury, SCI, Stimulation, Paralysis, rTMS, transcranial magnetic stimulation
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
Also called iTBS
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 rTMSOther
Also called Sham iTBS, Sham stimulation
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Motor trainingBehavioural
Also called Exercise training, Hand training
The motor training will be focused on participant's hand motor function such as grasping function.
| Study group | Role | What they receive |
|---|---|---|
| rTMS first and then sham-rTMS | Experimental | rTMS or sham-rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention. In this Arm, participants will have rTMS session first and then sham-rTMS. Receives: Other: rTMS; Other: Sham rTMS |
| Sham rTMS and then rTMS | Experimental | rTMS or sham-rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention. In this Arm, participants will have sham-rTMS session first and then rTMS. Receives: Other: rTMS; Other: Sham rTMS |
| rTMS with motor training | Experimental | Subjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training. Receives: Other: rTMS; Behavioral: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potentials (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 measured in millivolts will be averaged across trials. MEPs will be collected before (pre) and after (post) each intervention and the post-MEP amplitude will be normalized by pre-MEP amplitude. Therefore, the MEP outcomes reported will be "(post-MEP/pre-MEP)x100".
Measured: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", MEPs will be measured twice, before the start of the first session and after the 10th session, at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start10 Apr 2025
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover between Arm 1 and Arm 2. Arm 3 is a single group study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
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
- Investigators
- Hang Jin Jo, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815601
- Sponsor's protocol ID
- 00007259
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2025
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation After Spinal Cord Injury to Improve Limb Function
- ClinicalTrials.gov ID
- NCT06815601
- Acronym / sponsor ID
- 00007259
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Cervical
- Keywords
- spinal cord injury, SCI, Stimulation, Paralysis, rTMS, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.
Detailed description
The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Crossover between Arm 1 and Arm 2. Arm 3 is a single group study.
| Arm | Type | Receives |
|---|---|---|
| rTMS first and then sham-rTMS | Experimental | Other: rTMS, Other: Sham rTMSrTMS or sham-rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention. In this Arm, participants will have rTMS session first and then sham-rTMS. |
| Sham rTMS and then rTMS | Experimental | Other: rTMS, Other: Sham rTMSrTMS or sham-rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention. In this Arm, participants will have sham-rTMS session first and then rTMS. |
| rTMS with motor training | Experimental | Other: rTMS, Behavioral: Motor trainingSubjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults between the ages of 18-75 years old who are right-handed
- Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)
Key exclusion criteria (8 listed)
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Ongoing major depression or altered cognitive status
- 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 |
|---|---|---|
| rTMSAlso: 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 | Sham rTMS and then rTMS, rTMS first and then sham-rTMS, rTMS with motor training |
| Sham rTMSAlso: Sham iTBS, Sham stimulationSham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used. | Other | Sham rTMS and then rTMS, rTMS first and then sham-rTMS |
| Motor trainingAlso: Exercise training, Hand trainingThe motor training will be focused on participant's hand motor function such as grasping function. | Behavioural | rTMS with motor training |
Primary outcome
Motor Evoked Potentials (MEP)
Time frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", MEPs will be measured twice, before the start of the first session and after the 10th session, at 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 measured in millivolts will be averaged across trials. MEPs will be collected before (pre) and after (post) each intervention and the post-MEP amplitude will be normalized by pre-MEP amplitude. Therefore, the MEP outcomes reported will be "(post-MEP/pre-MEP)x100".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Hang Jin Jo, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and Motor training in people with Spinal Cord Injury and Spinal Cord Injury Cervical, 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 2 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: finished, as of the sponsor's last update on 8 Sep 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?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Motor Evoked Potentials (MEP) (time frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", MEPs will be measured twice, before the start of the first session and after the 10th session, at 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 8 Sep 2026.