Neuromodulation to Improve Grasping Function After SCI
1 other identifier
interventional
54
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 23, 2026
April 1, 2026
1.2 years
February 19, 2026
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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)
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Grip force
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)
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Study Arms (4)
iTBS and PCMS
ACTIVE COMPARATORiTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
Sham iTBS and PCMS
SHAM COMPARATORSham 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 COMPARATORParticipants will complete iTBS and PCMS with exercise for 10 sessions.
Sham iTBS and sham PCMS with exercise
SHAM COMPARATORParticipants will complete sham stimulation with exercise for 10 sessions.
Interventions
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.
During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.
The motor training will be focused on participant's hand motor function such as grasping function.
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 iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The State University of New York at Buffalo
Buffalo, New York, 14214, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 25, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share