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

July 14, 2020 updated by: Ela B. Plow, The Cleveland Clinic

Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Transcranial Direct Current Stimulation
  • tDCS
  • Transcranial 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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.
The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Telemedicine & Advanced Technology Research Center

Investigators

  • Principal Investigator: Ela B Plow, PhD PT, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-334
  • RPC 2016-195 (Other Grant/Funding Number: Conquer Paralysis Now)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The Investigator not be sharing or releasing any study data to third parties outside the Cleveland Clinic

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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