Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury

NCT00387673 | Completed Results DMC

• 1 other identifier: B4439-R
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

electrical stimulation; hand; Rehabilitation; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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

  Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing

Study Arms (3)

Arm 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

Arm 2

ACTIVE COMPARATOR

a 6-week period of 2 hours somatosensory stimulation of the hand, without training

Behavioral: Somatosensory Stimulation and Massed Practice Training

Arm 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

Interventions

Somatosensory Stimulation and Massed Practice Training BEHAVIORAL

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.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Miami

Miami, Florida, 33125, 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

Results Point of Contact

• Title: Kristina Beekhuizen
• Organization: Miami VA Healthcare System

Kristina.Beekhuizen@va.gov

305-575-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2011
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-05

Locations

US (1)