Neuromodulation After Spinal Cord Injury to Improve Limb Function

NCT06815601 | Recruiting

• 1 other identifier: 00007259
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury; Spinal Cord Injury Cervical

Keywords

spinal cord injury; SCI; Stimulation; Paralysis; rTMS; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Motor evoked potentials (MEP)

  Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.

  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.

Secondary Outcomes (2)

• Maximum voluntary contraction (MVC)

  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.

• Power Grip Forces

  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.

Study Arms (3)

rTMS

ACTIVE COMPARATOR

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

Other: rTMS

Sham rTMS

SHAM COMPARATOR

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

Other: Sham rTMS

rTMS with motor training

ACTIVE COMPARATOR

Subjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training.

Other: rTMS; Behavioral: Motor training

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).

Also known as: iTBS

rTMS; rTMS with motor training

Sham rTMS OTHER

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

Also known as: Sham iTBS, Sham stimulation

Sham rTMS

Motor training BEHAVIORAL

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

Also known as: Exercise training, Hand training

rTMS with motor training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

The Kimball Tower at The State University of New York at Buffalo

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hang Jin Jo, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hang Jin Jo, PhD

CONTACT

716-829-2905; hangjinj@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 7, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)