Neuromodulation to Improve Grasping Function After SCI

Neuromodulation to Improve Grasping Function After Spinal Cord Injury

The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: iTBS; Other: Sham iTBS; Behavioral: Exercise; Other: Sham PCMS; Other: PCMS

Detailed Description

The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hang Jin Jo, PhD; Phone Number: 716-829-2905; Email: hangjinj@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • Recruiting
      • The State University of New York at Buffalo
      • Contact: Karen Barnes; Phone Number: 716-829-6718; Email: barneska@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For individuals with SCI:

• Ages 18-75 years
• Chronic SCI (≥1 year of injury)
• Cervical injury at C8 or above
• Individuals who have MEP responses in at least one FDI muscle

Exclusion Criteria:

• Uncontrolled medical problems including pulmonary or cardiovascular disease
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke
• 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
• Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iTBS and PCMS; iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.	Other: iTBS; 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).; Other: PCMS; During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.
Sham Comparator: Sham iTBS and PCMS; Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.	Other: Sham iTBS; Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.; Other: PCMS; During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.
Active Comparator: iTBS and PCMS with exercise; Participants will complete iTBS and PCMS with exercise for 10 sessions.	Other: iTBS; 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).; Behavioral: Exercise; The motor training will be focused on participant's hand motor function such as grasping function.; Other: PCMS; During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.
Sham Comparator: Sham iTBS and sham PCMS with exercise; Participants will complete sham stimulation with exercise for 10 sessions.	Other: Sham iTBS; Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.; Other: Sham PCMS; During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor evoked potential (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 the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum voluntary contraction (MVC)	Individuals will perform a MVC of the targeted hand muscle (first dorsal interosseous) through surface EMG electrodes. The investigators will collect two MVC trials and use the average of the two.	For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Grip force	Grip force will be assessed with hand grip dynamometer. The highest value of the three trials will be used.	For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)	TRI-HFT is clinical assessment tool to measure specifically unilateral pinch and grasp hand function.	For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: STUDY00009877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No