Spinal Cord InjuryNCT00387673
Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury
A study testing Somatosensory Stimulation and Massed Practice Training in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Somatosensory Stimulation and Massed Practice Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
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.
Read the 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:
- 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
- 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:
- 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.
- 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.
- 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Somatosensory Stimulation and Massed Practice Training
- Keywords
- electrical stimulation, hand, Rehabilitation, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory Stimulation and Massed Practice TrainingBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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); Receives: 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 Receives: 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 Receives: Behavioral: Somatosensory Stimulation and Massed Practice Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387673
- Sponsor's protocol ID
- B4439-R
- Status last verified
- May 2017
- First submitted
- 12 Oct 2006
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
- ClinicalTrials.gov ID
- NCT00387673
- Acronym / sponsor ID
- B4439-R
- Conditions
- Spinal Cord Injury
- Keywords
- electrical stimulation, hand, Rehabilitation, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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:
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Somatosensory Stimulation and Massed Practice Training6 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); |
| Arm 2 | Active comparator | Behavioral: Somatosensory Stimulation and Massed Practice Traininga 6-week period of 2 hours somatosensory stimulation of the hand, without training |
| Arm 3 | Placebo comparator | Behavioral: Somatosensory Stimulation and Massed Practice Traininga 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatosensory Stimulation and Massed Practice Traininga) 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. | Behavioural | Arm 1, Arm 2, Arm 3 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatosensory Stimulation and Massed Practice Training in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.