Neuromodulation After Spinal Cord Injury to Improve Limb Function

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06815601
Status
Recruiting

Conditions

  • Spinal Cord Injury
  • Spinal Cord Injury Cervical

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • rTMS — 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 rTMS — OTHER
    Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
  • Motor training — BEHAVIORAL
    The motor training will be focused on participant's hand motor function such as grasping function.

Study Details

The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.

Key Dates

Start date
Apr 10, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: rTMS
    rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
  • Sham Comparator: Sham rTMS
    Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
  • Active Comparator: rTMS with motor training
    Subjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training.

Primary Outcome Measure

Motor evoked potentials (MEP) [ Time Frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Kimball Tower at The State University of New York at BuffaloBuffaloNew York14214
Karen Barnes
(716) 829-6718
Hang Jin Jo, PhD (PRINCIPAL_INVESTIGATOR)

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