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Clinical Trials/NCT01539109
NCT01539109
Completed
Not Applicable

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

The Cleveland Clinic1 site in 1 country20 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
The Cleveland Clinic
Enrollment
20
Locations
1
Primary Endpoint
Change in Upper Limb Function from Baseline
Status
Completed
Last Updated
5 years ago

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
October 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ela B. Plow

Project Scientist

The Cleveland Clinic

Eligibility 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
  • Implanted pumps, shunts, or neurostimulators
  • Neurologic condition affecting sensorimotor systems
  • Brain tumor
  • Substance abuse
  • Damaged skin on the scalp
  • Concurrent upper limb rehabilitation

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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