Neuromodulation for Spinal Cord Injury

Overseen By Hang Jin Jo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: Antipsychotics

Disqualifiers: Pulmonary, Cardiovascular, Depression, Psychosis, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Individuals who have MEP responses in at least one FDI muscle

For individuals with SCI:

I am between 18 and 75 years old.

Exclusion Criteria

Pregnant females

I do not have any uncontrolled heart or lung problems.

History of seizures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either active or sham iTBS and PCMS with or without exercise for 10 sessions

4 weeks

10 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation
• Paired Corticospinal Motoneuronal Stimulation

How Is the Trial Designed?

Group I: iTBS and PCMS Active Control 2 Interventions

iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.

Group II: iTBS and PCMS with exercise Active Control 3 Interventions

Participants will complete iTBS and PCMS with exercise for 10 sessions.

Group III: Sham iTBS and PCMS Placebo Group 2 Interventions

Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.

Group IV: Sham iTBS and sham PCMS with exercise Placebo Group 2 Interventions

Participants will complete sham stimulation with exercise for 10 sessions.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+