Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation
2 other identifiers
interventional
20
1 country
1
Brief Summary
The purpose of this study is to investigate whether combining a noninvasive method of brain stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of training of the affected upper limbs in patients with incomplete Spinal Cord Injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 16, 2020
July 1, 2020
7.9 years
February 16, 2012
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Upper Limb Function from Baseline
Upper limb function will be measured by the Upper Extremity Motor Score (UEMS), capacity tasks in the form of the Grasp and Release Task (GRT) test, and pinch grip impariment that will be measured by a maximum voluntary isometric pinch force.
Strength, activities and impairments will be measured at The patient will receive TMS during at baseline, post-2 weeks, post-4 weeks and 3-month followup
Secondary Outcomes (2)
Magnetic Resonance Imaging (MRI) of the brain
The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks
Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS)
The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks
Study Arms (2)
Rehab and tDCS
EXPERIMENTALPatients in this group will receive Noninvasive brain stimulation: tDCS, during rehabilitation exercises of the weak upper limbs for 2 hours per day, 5 times a week, for 2 weeks. tDCS is Transcranial Direct Current Stimulation. Prior to this 2-week intervention phase, all patients will be monitored over a 2-week control phase.
Rehab and sham tDCS
SHAM COMPARATORPatients in this group will receive Sham tDCS: placebo noninvasive brain stimulation, during rehabilitation exercises of the weak upper limbs for 2 hours per day, 5 times a week, for 2 weeks. tDCS is Transcranial Direct Current Stimulation. Prior to this 2-week intervention phase, all patients will be monitored over a 2-week control phase
Interventions
Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.
TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered to patients in the experimental group for 2 hr each day for 5 days a week for 2 weeks in conjunction with therapy for the affected hand.
Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.
Eligibility Criteria
You may qualify if:
- Diagnosed with incomplete spinal cord injury (iSCI) that occurred at least 6 months ago
You may not qualify if:
- History of epilepsy in a first degree relative
- Use of anticonvulsants
- Pregnant
- Implanted pumps, shunts, or neurostimulators
- Neurologic condition affecting sensorimotor systems
- Brain tumor
- Dementia
- Substance abuse
- Stroke
- Damaged skin on the scalp
- Concurrent upper limb rehabilitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Potter-Baker KA, Janini DP, Lin YL, Sankarasubramanian V, Cunningham DA, Varnerin NM, Chabra P, Kilgore KL, Richmond MA, Frost FS, Plow EB. Transcranial direct current stimulation (tDCS) paired with massed practice training to promote adaptive plasticity and motor recovery in chronic incomplete tetraplegia: A pilot study. J Spinal Cord Med. 2018 Sep;41(5):503-517. doi: 10.1080/10790268.2017.1361562. Epub 2017 Aug 7.
PMID: 28784042DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ela B Plow, PhD PT
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Scientist
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 27, 2012
Study Start
November 1, 2011
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
July 16, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
The Investigator not be sharing or releasing any study data to third parties outside the Cleveland Clinic