Enhancement of Hand Motor Function After Cervical Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Pittsburgh Medical Center Presbyterian Hospital
University of Pittsburgh
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01915095
First received: July 19, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Very often, people have difficulty doing things with their hands after experiencing a spinal cord injury (SCI). This can cause problems performing even the simplest of everyday tasks such as eating, grasping, writing, and many others. The purpose of this research study is to examine how the central nervous system contributes to the control of hand movements after cervical SCI and promote the recovery of hand movements by using non-invasive brain stimulation and motor training. Results from this study could provide information that can be used to develop the best possible rehabilitation for individuals with SCI to help improve hand and arm function.


Condition Intervention
Spinal Cord Injury
Procedure: High frequency non-invasive repetitive transcranial magnetic stimulation
Procedure: Sham rTMS over control brain area

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Enhancement of Hand Motor Function After Cervical Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome measures of this study are muscle responses evoked by using transcranial magnetic stimulation of the primary motor cortex and electrical stimulation of a peripheral nerve in the arm [ Time Frame: Measurements will be taken immediately at one, two, and three months after the study intervention. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: rTMS
rTMS stimulation with magnetic pulses using transcranial magnetic stimulation and electrical stimulation targeting finger and wrist muscles during precision grip and wrist voluntary contractions
Procedure: High frequency non-invasive repetitive transcranial magnetic stimulation
Stimulation with magnetic pulses using transcranial magnetic stimulation and electrical stimulation of a peripheral nerve in the arm
Sham Comparator: Sham rTMS
rTMS stimulation with magnetic pulses using transcranial magnetic stimulation and electrical stimulation targeting finger and wrist muscles during precision grip and wrist voluntary contractions
Procedure: High frequency non-invasive repetitive transcranial magnetic stimulation
Stimulation with magnetic pulses using transcranial magnetic stimulation and electrical stimulation of a peripheral nerve in the arm
Active Comparator: Sham rTMS over control brain area
rTMS will be applied over the dorsolateral prefrontal cortex (DLPFC) or at the leg representation of the primary motor cortex
Procedure: Sham rTMS over control brain area
rTMS stimulation with magnetic pulses using transcranial magnetic stimulation and electrical stimulation applied over the dorsolateral prefrontal cortex or at the leg representation of the primary motor cortex

Detailed Description:

Hand motor function is largely disrupted in veterans with cervical spinal cord injury (SCI). This has tremendous impact in daily-life activities. This study will examine physiological changes in pathways controlling hand motor function after cervical SCI and novel methods to enhance the recovery of hand motor function by combining non-invasive repetitive brain stimulation with motor training. The repetitive brain stimulation will occur using a wire coil placed over the participants head. When activated, this coil will generate a magnetic pulse over a specified area of the head. During training, we will monitor muscle activity through the use of surface electrodes. Subjects will perform precision grip and wrist movements. Impairment in hand function is a major problem after stroke, amyotrophic lateral sclerosis, multiple sclerosis, and other motor disorders, therefore, our work may also be relevant for individuals with other lesions of the nervous system.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 of injury)
  • Cervical injury at C8 or above (tetraplegia)
  • Intact or impaired but not absent lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the American Spinal Injury Association (ASIA) sensory scores,
  • The ability to produce a visible precision grip force with one hand
  • Individuals who have the ability to pick up a small object (large paperclip) from a table independently
  • Able to perform 30 or more of wrist flexion and extension (measured by a goniometer)

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 or herniated cervical disk
  • Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915095

Contacts
Contact: Monica A Perez, PhD (412) 383-6563 Monica.Perez@va.gov
Contact: Christine N Sanserino, BSN BA (412) 624-7733 cns47@pitt.edu

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Nicholas L Squeglia    (412) 360-2387    nicholas.squeglia@va.gov   
Contact: Mary B Walsh, RN    (412) 360-2256    mary.walsh3@va.gov   
Principal Investigator: Monica Alicia Perez, PhD         
Sponsors and Collaborators
University of Pittsburgh Medical Center Presbyterian Hospital
University of Pittsburgh
Investigators
Principal Investigator: Monica Alicia Perez, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01915095     History of Changes
Other Study ID Numbers: B0815-R
Study First Received: July 19, 2013
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
spinal cord injury
motor learning
electrophysiology

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014