Clinical trial NCT01539109: Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation
Official title: Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Incomplete Spinal Cord Injury
Quadriplegia
Tetraplegia
SCI
Spinal Cord Disease
Spinal Cord Injury
iSCI
Transcranial Direct Current Stimulation
tDCS
SCI recovery
brain stimulation
rehabilitation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Telemedicine & Advanced Technology Research Center
First posted: 2012-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in Upper Limb Function from Baseline
timeFrame: 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 outcomes:
measure: Magnetic Resonance Imaging (MRI) of the brain
timeFrame: The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks
measure: Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS)
timeFrame: The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ela B Plow, PhD PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.