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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 : Completed
First Posted : February 27, 2012
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Telemedicine & Advanced Technology Research Center
Information provided by (Responsible Party):
Ela B. Plow, The Cleveland Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: Rehabilitation Procedure: Noninvasive brain stimulation: tDCS Procedure: Sham tDCS: placebo noninvasive brain stimulation Not Applicable

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. The Investigators objective is to directly modulate adaptive plasticity in these regions of the brain to enhance function of the upper limb in iSCI. The Investigators 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke
Actual Study Start Date : November 2011
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Rehabilitation
Patients will receive training upon tasks of daily living. Patients 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
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
 Behavioral: Rehabilitation
Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT01539109


Locations
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United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Telemedicine & Advanced Technology Research Center
Investigators
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Principal Investigator: Ela B Plow, PhD PT The Cleveland Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ela B. Plow, Project Scientist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01539109    
Other Study ID Numbers: 16-334
RPC 2016-195 ( Other Grant/Funding Number: Conquer Paralysis Now )
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Investigator not be sharing or releasing any study data to third parties outside the Cleveland Clinic
Keywords provided by Ela B. Plow, The Cleveland Clinic:
Incomplete Spinal Cord Injury
Quadriplegia
Tetraplegia
SCI
Spinal Cord Disease
Spinal Cord Injury
 iSCI
Transcranial Direct Current Stimulation
tDCS
SCI recovery
brain stimulation
rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System