Recruiting

Intermittent Theta Burst Stimulation & Corticospinal Stimulation

Sponsor:

State University of New York at Buffalo

Code:

NCT07433959

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

iTBS

Sham iTBS

PCMS

Sham PCMS

Exercise

Study Details

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.

Conditions

Spinal Cord Injury

Study ID

NCT07433959

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 iTBS

Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.

PCMS

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

During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.

Exercise

The motor training will be focused on participant's hand motor function such as grasping function.

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 and Locations

Central contacts

Hang Jin Jo, PhD

716-829-2905hangjinj@buffalo.edu

Locations

The State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14214

Contacts

Karen Barnes

716-829-6718barneska@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-04-23.