Recruiting
Early Phase 1

Non-Invasive Stimulation

Sponsor:

Medical University of South Carolina

Code:

NCT06989905

Conditions

Spinal Cord Injury

Tetraplegia/Tetraparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Up-conditioning of the wrist extensor motor evoked potential

Study Details

Brief summary:

Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where participants receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor).

Investigators will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell investigators about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.

Conditions

Spinal Cord Injury

Tetraplegia/Tetraparesis

Study ID

NCT06989905

Start date

May 27, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (≥18 yrs old)
  • A history of injury to spinal cord at or above C6
  • >6 months post SCI
  • Weak wrist extension at least unilaterally
  • Expectation that current medication will be maintained without change for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted.

Exclusion Criteria:

  • Motoneuron injury
  • Medically unstable condition
  • Cognitive impairment
  • A history of epileptic seizures
  • Metal implants in the cranium
  • Implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
  • Extensive use of functional electrical stimulation to the arm on a daily basis
  • Pregnancy (due to changes in posture and potential medical instability)
  • Contraindications to MRI
  • No measurable MEP elicited in the ECR
  • Unable to produce any voluntary ECR EMG activity

Study Design

Enrollment

11 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Operant Up-Conditioning of the Motor Evoked Potential

The intervention consists of approximately 6 baseline sessions and 24 conditioning sessions at a pace of 3 sessions/week, 1-2 hour duration, over 10 weeks. At the beginning of each session, electromyographic (EMG) recording and nerve stimulating electrodes are placed over the arm. In all sessions, motor evoked potentials (MEPs) will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).

Interventions

Up-conditioning of the wrist extensor motor evoked potential

At the beginning of each session, EMG recording and nerve stimulating electrodes are placed over the arm. In all sessions, MEPs will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).

Primary outcome measure

  • Extensor Carpi Radialis (ECR) Motor Evoked Potential (MEP) amplitude [ Time Frame: Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10) ]

Central Contacts and Locations

Central contacts

Recruitment Contact

843-792-6313stecb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Allison Lewis, DPT, PhD

843-792-6313lewisaf@musc.edu

Principal Investigator:

Allison Lewis, DPT, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Central Nervous System
  • Nervous System
  • Rehabilitation Studies
  • Spinal Cord
  • spinal cord injury
  • upper extremity
  • upper limb
  • motor impairment
  • tetraplegia
  • quadriplegia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-30.