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Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation

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ClinicalTrials.gov Identifier: NCT01539109
Recruitment Status : Recruiting
First Posted : February 27, 2012
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Telemedicine & Advanced Technology Research Center
Information provided by (Responsible Party):
Ela B Plow, PhD, PT, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE February 16, 2012
First Posted Date  ICMJE February 27, 2012
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE November 2011
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
Change in Upper Limb Function from Baseline [ Time Frame: 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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
Change in Upper Limb Function from Baseline [ Time Frame: Strength, activities and impairments will be measured at The patient will receive TMS during at baseline, post-5 weeks, post-10 weeks and 3-month followup ]
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.
Change History Complete list of historical versions of study NCT01539109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • Magnetic Resonance Imaging (MRI) of the brain [ Time Frame: The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks ]
    MRI will be used to measure changes in structure of the brain and its pathways as a result of training
  • Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS) [ Time Frame: The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks ]
    TMS is a noninvasive technique of brain stimulation that examines the activity of regions of brain devoted to movement. Without implanting, or injecting or penetrating the brain, simply by using scalp-based recordings, TMS can assess functionality of the brain.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
  • Magnetic Resonance Imaging (MRI) of the brain [ Time Frame: The patient will receive MRI during at baseline, post-5 weeks, and post-10 weeks ]
    MRI will be used to measure changes in structure of the brain and its pathways as a result of training
  • Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS) [ Time Frame: The patient will receive TMS during at baseline, post-5 weeks, and post-10 weeks ]
    TMS is a noninvasive technique of brain stimulation that examines the activity of regions of brain devoted to movement. Without implanting, or injecting or penetrating the brain, simply by using scalp-based recordings, TMS can assess functionality of the brain.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation
Official Title  ICMJE Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke
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.
Detailed Description

The long-term objective of this study is to optimize the rehabilitative potential in spinal cord injury (SCI) by maximally harnessing the potential available for functional neural plasticity. SCI is an important cause of serious, long-term disability in young adults. This fact, further complicated by rising disability-related costs, makes SCI a significant economic and social burden. Upper limb dysfunction is one of the most prevalent and debilitating impairments. More than 75% of patients with quadriplegia (paralysis of all 4 limbs following spinal cord injury in neck and upper back) prioritize return of upper limb function over any other lost function. Alleviating deficits of the upper limb may represent a cost-effective stategy to reducing the burden of SCI.

Although various exercise programs and neuromuscular stimulation methods have been employed to mitigate functional impairments of the arm and hand, success of these modalities is still debated. Evidence for efficacy of rehabilitation is inconclusive as outcomes are variable, confounded by methodological issues, and have shown poor generalizability. It is now speculated that limited succcess of rehabilitation emerges from inability of current methods to adequately harness the potential for significant neuroplasticity available in SCI.

Even though the site of damage in SCI does not involve the brain, the neural networks in the brain that control movement of the arm and hand are markedly affected. These regions lose their territory that the investigators argue could hamper effects of upper limb therapy. Our objective is to directly modulate adaptive plasticity in these regions of the brain to enhance function of the upper limb in iSCI. Our central hypothesis is that noninvasive brain stimulation, called transcranial direct current stimulation (tDCS), when delivered concurrently with rehabilitation will generate synergistic functional advantage. Adaptive plasticty would be obeserved as changes in structure of pathways emerging from the brain and the individual's function.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • Behavioral: Rehabilitation
    Patients will receive training upon tasks of daily living. They will perform these exercises in our laboratory under the supervision of qualified personnel.
  • Procedure: Noninvasive brain stimulation: tDCS
    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.
    Other Names:
    • tDCS
    • Transcranial Stimulation
    • Transcranial Direct Current Stimulation
    • Brain stimulation
  • Procedure: Sham tDCS: placebo noninvasive brain stimulation
    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.
    Other Names:
    • sham tDCS
    • placebo tDCS
Study Arms
  • Experimental: Rehab and tDCS
    Patients 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.
    Interventions:
    • Behavioral: Rehabilitation
    • Procedure: Noninvasive brain stimulation: tDCS
  • Sham Comparator: Rehab and sham tDCS
    Patients 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:
    • Behavioral: Rehabilitation
    • Procedure: Sham tDCS: placebo noninvasive brain stimulation
Publications * 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.

*   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
 (submitted: March 6, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2012)
10
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with incomplete spinal cord injury (iSCI) that occurred at least 6 months ago

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Ela B Plow, PhD PT 216-445-4589 plowe2@ccf.org
Contact: Kyle J O'Laughlin, MS 216-445-6728 olaughk@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01539109
Other Study ID Numbers  ICMJE 16-334
RPC 2016-195 ( Other Grant/Funding Number: Conquer Paralysis Now )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: We will not be sharing or releasing any study data to third parties outside the Cleveland Clinic
Responsible Party Ela B Plow, PhD, PT, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Telemedicine & Advanced Technology Research Center
Investigators  ICMJE
Principal Investigator: Ela B Plow, PhD PT The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP