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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00387673
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 3
• Duration (Months): 56
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Behavioral: Somatosensory Stimulation and Massed Practice Training	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 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.
Active Comparator: Arm 2 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.
Placebo Comparator: Arm 3 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Miami	Miami	Florida	United States	33125

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00387673
• Other Study ID Numbers: B4439-R
• First Posted: Oct 13, 2006
• Last Update Posted: Jun 16, 2017
• Last Verified: May 1, 2017

• Keywords provided by VA Office of Research and Development: electrical stimulation; hand; Rehabilitation; spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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); 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.	a 6-week period of 2 hours somatosensory stimulation of the hand, without training 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.	a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training 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.
Period Title: Overall Study
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Effect of Prolonged Electrical Stimulation on Neural Plastici
Arm/Group Description
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age (years) []
Sex: Female, Male () []
Female	0
Male	0
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Project has officially closed. PI for this project has left VA without forwarding information.

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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); 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.	a 6-week period of 2 hours somatosensory stimulation of the hand, without training 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.	a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training 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.
Measure Participants	0	0	0

Adverse Events

Adverse Event Reporting Description	Project has officially closed. PI for this project has left VA without forwarding information.
Arm/Group Title	Project Closed
Arm/Group Description
All Cause Mortality
	Project Closed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Project Closed
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Project Closed
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.