Neuromodulation After Spinal Cord Injury to Improve Limb Function
NCT ID: NCT06815601
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-10
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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rTMS
rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
rTMS
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
Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
Sham rTMS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
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.
rTMS
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).
Motor training
The motor training will be focused on participant's hand motor function such as grasping function.
Interventions
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rTMS
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
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Motor training
The motor training will be focused on participant's hand motor function such as grasping function.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)
Exclusion Criteria
* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
* Any debilitating disease prior to the SCI that caused exercise intolerance
* Ongoing major depression or altered cognitive status
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Hang Jin Jo
Assistant Professor
Principal Investigators
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Hang Jin Jo, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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The Kimball Tower at The State University of New York at Buffalo
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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00007259
Identifier Type: -
Identifier Source: org_study_id
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