Grasping Function After Spinal Cord Injury

NCT03447509 | Terminated

• 1 other identifier: B2474-R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; neural control; motor function; hand movement

Outcome Measures

Primary Outcomes (1)

• Changes in amplitude of Motor evoked potential size

  At the stated minute interval TMS measurements are reassessed.

  Post treatment at minute 0, minute 10, minute30, minute 60.

Secondary Outcomes (1)

• Grip Strength and 9-hole peg test

  Post treatment at minute 0, minute 10, minute30, minute 60.

Study Arms (3)

Experiment 1a

ACTIVE COMPARATOR

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.

Device: iTMS; Other: Motor Task

Experiment 1b

ACTIVE COMPARATOR

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).

Device: iTMS; Other: Motor Task

Experiment 2

ACTIVE COMPARATOR

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.

Device: iTMS; Other: Motor Task; Device: Sham iTMS; Other: Training

Interventions

iTMS DEVICE

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

Experiment 1a; Experiment 1b; Experiment 2

Motor Task OTHER

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

Experiment 1a; Experiment 1b; Experiment 2

Sham iTMS DEVICE

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

Experiment 2

Training OTHER

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

Experiment 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Monica A Perez, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they receive real or sham Stimulation and/or real or sham Startle
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Magnetic Stimulation and Acoustic Startle

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 27, 2018
• Study Start: March 17, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)