Grasping Function After Spinal Cord Injury

NCT ID: NCT03447509

Last Updated: 2026-01-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The overall goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive brain stimulation and acoustic startle protocols with motor training. The investigators propose to study two basic grasping behaviors, which are largely used in most daily-life activities: a precision grip and a power grip.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Grasping behaviors, which are essential for daily-life functions, are largely impaired in individuals with cervical spinal cord injury (SCI). Although rehabilitative interventions have shown success in improving the ability to grasp following injury their overall effects remain limited. The goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive stimulation protocols with motor training. The investigators propose to study two basic grasping behaviors: a precision grip and a power grip. These behaviors are crucial because they provide the basis for a number human prehensile manipulations and are also necessary skills for eating, writing, dressing, and many other functions. Thus, the study results may have a direct impact on the quality of life for Veterans and their caregivers by enhancing their independence and level of care.

In Aim 1, the investigators will investigate the contribution of corticospinal and brainstem pathways to the control of hand muscles involved in precision and power grip after cervical SCI. Transcranial magnetic stimulation (TMS) will be used to examine transmission in corticospinal and intracortical pathways targeting finger muscles and an acoustic startle stimulus with and without TMS will be used to examine the contribution from brainstem pathways.

In Aim 2, the investigators propose to enhance the recovery of grasping by using novel tailored protocols of non-invasive repetitive TMS targeting late indirect (I) descending volleys (iTMS) and an acoustic startle stimuli. iTMS and startle will be used during precision and power grip movements in a task-dependent manner to induce cortical and subcortical plasticity and enhance voluntary output of hand muscles. Later, iTMS and startle will be applied in a task-dependent manner during a motor training task that involves precision and power grip. These unique approaches aim at promoting neuroplasticity during functionally relevant grasping movements has not been used before.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Magnetic Stimulation and Acoustic Startle
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will not know if they receive real or sham Stimulation and/or real or sham Startle

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experiment 1a

Examine physiological mechanisms contributing to the control of precision and power grip behaviors. To accomplish this aim the investigators propose to complete one main experiment. The investigators will test the hypotheses that there are two fundamentally distinct modes of hand operation after SCI. One involves brainstem pathways, and permits whole-hand 'power grip', while the other involves corticospinal and motor cortical connections, and allows a wide range of fractionated finger movements (precision grip) after SCI. Measurements of corticospinal, reticulospinal, and motoneuron excitability will be tested during index finger abduction, precision and power grip.

Group Type ACTIVE_COMPARATOR

iTMS

Intervention Type DEVICE

Small magnetic pulse will be given to the brain in a non invasive manner.

Motor Task

Intervention Type OTHER

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

Experiment 1b

To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and/or an acoustic startle stimuli to test the hypothesis that induced-plasticity protocols (iTMS and startle stimuli) will enhance EMG and force output in hand muscles during grasping. In a randomized sham crossover design, SCI and controls will be assigned to two groups: (1) iTMS applied during precision and power grip (two randomized sessions), and (2) startle applied during precision and power grip (two randomized sessions).

Group Type ACTIVE_COMPARATOR

iTMS

Intervention Type DEVICE

Small magnetic pulse will be given to the brain in a non invasive manner.

Motor Task

Intervention Type OTHER

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

Experiment 2

To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and/or acoustic startle with precision and power grip training to test the hypothesis that 'precision and power grip training outcomes will be enhanced by iTMS and startle induced plasticity'. In a randomized sham controlled design, SCI and control subjects will be assigned to: training+iTMS and training+sham iTMS and training+startle and training+sham startle.

Group Type ACTIVE_COMPARATOR

iTMS

Intervention Type DEVICE

Small magnetic pulse will be given to the brain in a non invasive manner.

Motor Task

Intervention Type OTHER

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

Sham iTMS

Intervention Type DEVICE

Sham or fake stimulation will be given to the brain in a non invasive manner.

Training

Intervention Type OTHER

The participant will be instructed to do repetitive motor movements with their arm or hand.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iTMS

Small magnetic pulse will be given to the brain in a non invasive manner.

Intervention Type DEVICE

Motor Task

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

Intervention Type OTHER

Sham iTMS

Sham or fake stimulation will be given to the brain in a non invasive manner.

Intervention Type DEVICE

Training

The participant will be instructed to do repetitive motor movements with their arm or hand.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participants who are unimpaired healthy controls:

* Male and females between ages 18-85 years
* Right handed
* Able to complete precision grips with both hands
* Able to complete full wrist flexion-extension bilaterally

Participants who have had a spinal cord injury:

* Male and females between ages 18-85 years
* Chronic SCI (\> 1 year post injury)
* Spinal Cord injury at C8 or above
* Intact or impaired but not absent innervations in dermatomes C6. C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores
* The ability to produce a visible precision grip force with one hand
* Able to perform some small wrist flexion and extension
* ASIA A,B,C, or D

Exclusion Criteria

* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
* Any debilitating disease prior to the SCI that caused exercise intolerance
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of head injury or stroke
* Pacemaker
* Metal plate in skull
* History of seizures
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
* Pregnant females
* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Monica A Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2474-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rebuilding Inter-limb Transfer in Cervical SCI
NCT06440538 RECRUITING EARLY_PHASE1
AIH for Spinal Cord Repair
NCT03780829 RECRUITING EARLY_PHASE1
Cervical Transcutaneous SCS for TBI
NCT07147816 RECRUITING NA