Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries Tetraplegia, Unspecified, Incomplete, Chronic | Device: transcranial direct current stimulation Behavioral: Intensive upper extremity motor training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Hand Recovery With Neuromodulation in Tetraplegia |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Active tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
|
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: Intensive upper extremity motor training This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
|
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
|
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: Intensive upper extremity motor training This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth Powell, MS | (859) 323-6889 | elizabeth.salmon@uky.edu |
United States, Kentucky | |
University of Kentucky at Cardinal Hill Rehabilitation Hospital | Recruiting |
Lexington, Kentucky, United States, 40504 | |
Contact: Elizabeth Powell, MS 859-323-6889 elizabeth.salmon@uky.edu |
Principal Investigator: | Sara Salles, MD | University of Kentucky |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 14, 2019 | ||||||
First Posted Date ICMJE | May 17, 2019 | ||||||
Last Update Posted Date | March 3, 2021 | ||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Spinal Cord Independence Measure [ Time Frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up ] This evaluates self-care, respiration and sphincter management, and mobility.
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Improving Hand Recovery With Neuromodulation in Tetraplegia | ||||||
Official Title ICMJE | Improving Hand Recovery With Neuromodulation in Tetraplegia | ||||||
Brief Summary | This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation. | ||||||
Detailed Description | This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
36 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
|
||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03954496 | ||||||
Other Study ID Numbers ICMJE | 201810171642 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Responsible Party | Sara Shahid Salles, University of Kentucky | ||||||
Study Sponsor ICMJE | Sara Shahid Salles | ||||||
Collaborators ICMJE | Wings for Life | ||||||
Investigators ICMJE |
|
||||||
PRS Account | University of Kentucky | ||||||
Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |