- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906424
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California Los Angeles
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San Juan Capistrano, California, United States, 92675
- Strides SCI Functional Fitness
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: ASIA C
- Spinal cord injury 1 or more years prior
- Non progressive SCI at C7 or higher
- Half of key muscles below neurological level having a motor score of less than 2/5
- Ability to commit to home exercises and 12 week participation
- Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities
- Not dependent on ventilation support
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities
- No clinically significant depression or ongoing drug abuse
- Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period
- No current anti-spasticity regimen
- Must not have received botox injections in the prior six months
- Be unable to use upper extremity for functional tasks
Exclusion Criteria:
- Pregnancy
- No functional segmental reflexes below the lesion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control Grp#1: Training w/ and w/o Stim
Control- Group #1: 4 weeks training without any transcutaneous electrical stimulation followed by 2 weeks of training plus transcutaneous electrical spinal cord stimulation applied to one or two locations of the cervical (neck) region of the spinal cord.
|
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
|
ACTIVE_COMPARATOR: Grp#2: Training+Single Site Stimulation
Group #2: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to one location along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation
|
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
|
ACTIVE_COMPARATOR: Grp #3: Training + Two Site Stimualtion
Group #3: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to two locations along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation
|
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in sensorimotor function in arms and hands
Time Frame: 12 weeks
|
Subjects will be tested by several measures of sensory and motor function, as well as self-assessments regarding quality of life and independence, at the beginning of the study and at each testing session. These tests include: American Spinal Injury Association (ASIA) scoring system. Box and block CUE (Capabilities of Upper Extremity) GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) SCIM (Spinal Cord Independence Measure) Ashworth Spasticity scale: Penn Spasm Frequency VAS (Visual Analog Scale) for Spasticity) |
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Victor R Edgerton, PhD, University of California, Los Angeles
- Principal Investigator: Nicholas Terrafranca, DPM, NeuroEnabling Technologies, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NETI201307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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