Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI
Starting soon · Not applicable
Conditions studied: Spinal Cord Injury, Spinal Cord Disease, Spinal Cord Injuries (SCI)
In brief
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.
Key facts
- Study ID
- NCT06698224
- Run by
- Kessler Foundation
- People needed
- 14
- Starts
- 2025-01-02
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2024-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- At least 18 years of age
- Non-progressive cervical SCI
- Greater than or equal to 6-months post spinal cord injury
- Stable medical condition
- Viable median and ulnar nerve as evident from MMR and M-Wave recordings
- Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.
You may not qualify if…
- Ventilator Dependent
- Untreated fracture or pressure ulcer
- Untreated psychiatric disorder or ongoing drug abuse
- Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
- Skeletal muscle Botox injections less than 6 months prior
- Previous tendon transfer of the arm or arms
- Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
- Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- Unable or unwilling to wean from anti-spasticity medications
- History of seizure or epilepsy
- Metal in Head
- Cochlear implant
- Implanted brain stimulators
- Aneurysm clips
- Increased intracranial pressure (which lowers seizure threshold)
- Cardiac pacemaker
- Personal or family history of epilepsy
- Tricyclic antidepressants or neuroleptics (which lower seizure threshold)
- For healthy volunteer/participants:
- Inclusion Criteria:
- At least 18 years of age
- Exclusion Criteria:
- Neurological injury or disease
- Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- Personal or family history of seizure or epilepsy
Where it is running
- Kessler Foundation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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