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Improving SCI Rehabilitation Interventions by Retraining the Brain

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ClinicalTrials.gov Identifier: NCT03892746
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ela B. Plow, The Cleveland Clinic

Brief Summary:

The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors.

This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 visits over a period of 3 weeks.

The Study will include the following site visits:

  • Eligibility Screening and Informed Consent Visit.
  • Four testing visit in which motor function of the upper limb and neurophysiology will be measured
  • Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation
  • Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits
  • a Follow-up visit completed 3 months after the completion of interventions

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injruy Device: Active tDCS + task oriented practice Device: Sham tDCS + task oriented practice Phase 1 Phase 2

Detailed Description:
This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 18 cervical spinal patients with upper limb impairments will receive non-invasive brain stimulation tDCS (Transcranial Direct Current Stimulation) to the area in the brain controlling the weaker muscle of the weakest upper limb while receiving training for 5 days a weeks for 3 weeks. The primary outcome will be motor limb impairment, and secondary outcomes will be tests of functional ability, spinal excitability, and strength and dexterity. Safety and feasibility of pairing tDCS with rehabilitation will also be explored and include adverse effects, subject/investigator blinding, and attrition to 3 month follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this phase I/II clinical trial, an anticipated 18 subjects will receive 15 sessions of upper limb training while receiving either active tDCS or sham tDCS to the target in the brain devoted to the weaker triceps of the weaker upper limb.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomly assigned by the Cleveland Clinic biostatistician to receive either active or sham tDCS. The tDCS will be pre-programmed with codes for active and sham stimulation. The code will be given to the intervention team by the biostatistician. Investigators analyzing functional outcome data and neurophysiology data will receive coded data that conceals the identity of the subject.
Primary Purpose: Treatment
Official Title: Improving SCI Rehabilitation Interventions by Retraining the Brain
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : September 29, 2022
Estimated Study Completion Date : September 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Active tDCS + task oriented practice Device: Active tDCS + task oriented practice
Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 5 days a week for 3 weeks.

Sham Comparator: Sham tDCS + task oriented practice Device: Sham tDCS + task oriented practice
Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 5 days a week for 3 weeks.




Primary Outcome Measures :
  1. Change in Upper Extremity Motor Score(UEMS) with Manual Muscle Testing [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    UEMS is used in Spinal Cord injury to identify strength(muscle power) in patients with spinal cord injury.

  2. Change in GRASSP [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients

  3. Change in Modified Ashworth Scale (MAS) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    MAS is used to measure spasticity of the upper limb

  4. Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    COPM is used to measure participation restrictions of Spinal Cord Injury Subjects

  5. Change in Wolf Motor Function Test (WMFT) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    WMFT is used to measure functional ability of the upper limbs.

  6. Change in Spinal Cord Independence Measure(SCIM) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    SCIM is a spinal cord injury measure that identifies activity limitations of self-care

  7. Change in excitability of cortical and corticospinal physiology (TMS) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    Transcranial magnetic stimulation will be used to test cortical and corticospinal physiology. The threshold of the biceps and triceps of the weaker upper limb will be collected. Motor maps dedicated to the biceps and triceps of the weaker upper limb will be collected. These motor maps will show the area and strength of neuronal control to the biceps and triceps of the weaker upper limb.

  8. Change in excitability of spinal physiology (H-reflex) [ Time Frame: From Baseline (0 weeks and 3 weeks) to after completion of 3 weeks of training and after end of 3 months of follow-up. ]
    Spinal pathways will be tested using peripheral nerve testing. During this testing H-reflex will be collected.


Other Outcome Measures:
  1. Safety and Feasibility [ Time Frame: Through entirity of study ]
    In line with this phase I/II clinical trial, safety and feasibility will be tested throughout this study. Vital signs (blood pressure, heart rate, respirations, blood oxygen saturation) will be recorded for each study session. During Intervention sessions we will ask a tDCS adverse effects questionnaire at the end of each session.

  2. TMS safety questionnaire [ Time Frame: Through entirity of study ]
    A TMS safety questionnaire will be asked at the end of the preintervention tests and the post intervention testing visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 1 year post injury
  • weakness of the triceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared biceps muscle, i.e., at least one muscle grade lower on the MRC scale.

Exclusion Criteria:

  • contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy.
  • pressure ulcers
  • traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale <5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics.
  • excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist
  • participating in ongoing upper-limb therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892746


Contacts
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Contact: Kyle J. O'Laughlin, MS 216-445-7841 olaughk@ccf.org
Contact: Ela Plow, PhD 216-445-4589 plowe2@ccf.org

Locations
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United States, New Jersey
Kessler Foundation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Leighann Martinez, BA    973-324-3557    LMartinez@kesslerfoundation.org   
Contact: Gail Forrest, PhD    973-324-3518    gforrest@kesslerfoundation.org   
Principal Investigator: Gail Forrest, PhD         
United States, Ohio
Louis B. Stokes Cleveland VA Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Kyle J. O'Laughlin, MS    216-445-7841    olaughk@ccf.org   
Contact: Svetlana Pundik, PhD         
Principal Investigator: Svetlana Pundik, PhD         
Lerner Research Institute; Cleveland Clinid Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Kyle J O'Laughlin, MS    216-445-7841    olaughk@ccf.org   
Contact: Ela Plow, PhD    216-445-4589    plowe2@ccf.org   
Principal Investigator: Ela Plow, PhD         
Sponsors and Collaborators
The Cleveland Clinic
United States Department of Defense
Investigators
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Principal Investigator: Ela Plow, PhD The Cleveland Clinic

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Responsible Party: Ela B. Plow, Principal Investigator, Staff, Neural Control Lab, Dept. of Biomedical Engineering, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03892746     History of Changes
Other Study ID Numbers: 18-972
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ela B. Plow, The Cleveland Clinic:
Cervical Spinal Cord Injury
tDCS
Transcranial Direct Current Stimulation
Upper limb
Rehabilitation
Brain Stimulation