ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury

This study is currently recruiting participants.
Verified by Department of Veterans Affairs, May 2008

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00387673
  Purpose

Electrical stimulation (pulses of electricity applied over the skin of your wrist) and activity-based hand exercise have been shown to improve motor skill and strength in individuals with stroke and have recently been shown to also have an effect on individuals with spinal cord injury. Therefore, the purpose of this research study is to investigate whether electrical stimulation alone or electrical stimulation followed by activity-based training produces gains in pinch strength (how hard you can squeeze your thumb and pointer finger together) and upper extremity function (how well your arm and hand can perform activities) in individuals with spinal cord injury.


Condition Intervention
Spinal Cord Injury
Behavioral: Somatosensory Stimulation and Massed Practice Training

MedlinePlus related topics:   Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study
Official Title:   Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Conduct pre-and post-training assessments of behavioral outcomes using:Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function, hand-held dynamometry to measure pinch grip strength, and Semmes-Weinstein Monofilam [ Time Frame: Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing ] [ Designated as safety issue: No ]

Estimated Enrollment:   36
Study Start Date:   October 2006
Estimated Study Completion Date:   October 2009
Estimated Primary Completion Date:   October 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
6 weeks of upper extremity training for 3 sessions/week, as follows:a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
2: Active Comparator
a 6-week period of 2 hours somatosensory stimulation of the hand, without training
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
3: Placebo Comparator
a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training
Behavioral: Somatosensory Stimulation and Massed Practice Training
a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.

Detailed Description:

Spinal cord injury (SCI) affects 10,000 individuals per year in the United States. Approximately one half of all individuals with SCI have tetraparesis due to cervical injury. Impaired hand function significantly limits the ability of individuals with cervical SCI to perform manual activities of daily living which affects these individuals physically, psychologically and socially. Preliminary research by this investigator suggests that somatosensory stimulation combined with activity-based training improves hand function and strength in individuals with incomplete cervical SCI. Further investigations on these novel techniques are warranted due to the need to establish proven effective rehabilitation techniques that promote recovery of function in individuals with SCI.

The purpose of this research study is to: 1)determine if somatosensory stimulation in the form of prolonged, peripheral nerve electrical stimulation can enhance the effect of an upper extremity activity-based training program in individuals with incomplete cervical SCI, and if so, 2) identify the operative neural mechanisms underlying the changes induced with the application of somatosensory stimulation.

The hypotheses of this study are that individuals with incomplete cervical SCI:

  1. a 6-week period of somatosensory stimulation of the hand, either alone or combined with activity-based training, will produce improvements in behavioral outcomes that are significantly greater than those produced by activity-based training preceded by a sham stimulation period
  2. this behavioral improvement will be associated with greater changes in cortical excitation than will be observed in subjects receiving activity-based training preceded by a sham stimulation period.

The specific objectives of this study are to:

  1. Recruit male and female volunteers with spastic paresis due to incomplete SCI with impaired hand function, and randomize subjects into 1 of 3 groups, each of which receives 6 weeks of upper extremity training for 3 sessions/week, as follows:a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
  2. Conduct pre-and post-training assessments of behavioral outcomes using:Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function, hand-held dynamometry to measure pinch grip strength, and Semmes-Weinstein Monofilament Testing to measure sensory function.
  3. Conduct pre-and post-training assessments of supraspinal motor recruitment, including motor evoked potential (MEP) amplitudes in response to transcranial magnetic stimulation and extent and duration of cortical silent period in response to transcranial magnetic stimulation; and spinal motoneuron excitability measured by F-wave amplitude and persistence.
  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Trace voluntary thumb movement or able to pick up small objects with a tenodesis grip
  • Between ages 18 and 60
  • Spastic paresis (manifest as spasms, clonus, and/or hyperreflexia) due to neurologically incomplete SCI
  • Medically stable
  • Communicate questions/needs and answer yes/no questions reliably.

Exclusion Criteria:

  • Altered cognitive status
  • Level of injury caudal to the C7 level
  • History of CVA, seizures
  • Implanted metal devices in the head, less than one year post injury, and severe spasticity of the muscles of the upper extremities (defined by a score of 2 or higher on the Modified Ashworth Spasticity Scale)
  • Patients with pacemakers will also be excluded from this study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387673

Contacts
Contact: Carlos Gomez-Orozco     (305) 575-7000 ext 6993     carlos.gomez-orozco@va.gov    
Contact: Alberto Martinez-Arizala, MD     (305) 324-3174     AMartine@med.miami.edu    

Locations
United States, Florida
VA Medical Center, Miami     Recruiting
      Miami, Florida, United States, 33125
      Contact: Luis Gonzalez     305-575-7000 ext 3179     Luis.Gonzalez2@Va.gov    
      Contact: Alberto Martinez-Arizala, MD     (305) 324-3174     AMartine@med.miami.edu    
      Principal Investigator: Kristina Beekhuizen, PhD PT            

Sponsors and Collaborators

Investigators
Principal Investigator:     Kristina Beekhuizen, PhD PT     VA Medical Center, Miami    
  More Information

Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Beekhuizen, Kristina - Principal Investigator )
Study ID Numbers:   B4439Z
First Received:   October 12, 2006
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00387673
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
electrical stimulation  
hand  
Rehabilitation  
spinal cord injury  

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers