Neuromodulation to Improve Grasping Function After SCI

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07433959
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • iTBS — OTHER
    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 — OTHER
    Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
  • PCMS — OTHER
    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 PCMS — OTHER
    During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.
  • Exercise — BEHAVIORAL
    The motor training will be focused on participant's hand motor function such as grasping function.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: iTBS and PCMS
    iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
  • Sham Comparator: Sham iTBS and PCMS
    Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
  • Active Comparator: iTBS and PCMS with exercise
    Participants will complete iTBS and PCMS with exercise for 10 sessions.
  • Sham Comparator: Sham iTBS and sham PCMS with exercise
    Participants will complete sham stimulation with exercise for 10 sessions.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The State University of New York at BuffaloBuffaloNew York14214
Karen Barnes
[email protected]
716-829-6718

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By research site
The State University of New York at Buffalo· Buffalo, NY

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