Neuromodulation After Spinal Cord Injury to Improve Limb Function

NCT ID: NCT06815601

Last Updated: 2025-04-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.

Conditions

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Spinal Cord Injury Spinal Cord Injury Cervical

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rTMS

rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type 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

Sham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type 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).

Motor training

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Sham rTMS

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

Intervention Type OTHER

Motor training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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iTBS Sham iTBS Sham stimulation Exercise training Hand training

Eligibility Criteria

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Inclusion Criteria

* Healthy adults between the ages of 18-75 years old who are right-handed
* Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)

Exclusion Criteria

For both healthy individuals and those with SCI:

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Hang Jin Jo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hang Jin Jo, PhD

Role: CONTACT

716-829-2905

Facility Contacts

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Karen Barnes

Role: primary

(716) 829-6718

Other Identifiers

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00007259

Identifier Type: -

Identifier Source: org_study_id

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