Directing Neuroplasticity to Improve Rehabilitative Outcomes of the Upper Limb in Incomplete Quadriplegia - Full Text View

Purpose

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	Intervention
Spinal Cord Injury	Behavioral: Rehabilitation Procedure: Noninvasive brain stimulation: tDCS Procedure: Sham tDCS: placebo noninvasive brain stimulation


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Directing Neuroplasticity to Improve Rehabilitative Outcomes of the Upper Limb in Incomplete Quadriplegia

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Magnetic Resonance Imaging (MRI) of the brain [ Time Frame: The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks ] [ Designated as safety issue: No ]
MRI will be used to measure changes in structure of the brain and its pathways as a result of training
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 ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	10
Study Start Date:	November 2011
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. They 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. They 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

Arms

Assigned Interventions

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. They 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. They 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

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. Our objective is to directly modulate adaptive plasticity in these regions of the brain to enhance function of the upper limb in iSCI. Our 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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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, antidepressants, or psychotropic medications (except anti-spasticity or pain medications)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539109

Contacts


Contact: Ela B Plow, PhD PT	216-445-4589	plowe2@ccf.org
Contact: Thelma Asare, MPH	216-445-6728	asaret@ccf.org

Locations


United States, Ohio
The Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Thelma Asare, MPH 216-445-6728 asaret@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

Telemedicine & Advanced Technology Research Center

Investigators


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

More Information


Responsible Party:	Ela B Plow, PhD, PT, Project Scientist, The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01539109 History of Changes
Other Study ID Numbers:	11-823 W81XWH-11-1-0707
Study First Received:	February 16, 2012
Last Updated:	April 19, 2016
Health Authority:	United States: Federal Government United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No
Plan Description:	We will not be sharing or releasing any study data to third parties outside the Cleveland Clinic

Keywords provided by The Cleveland Clinic:


Spinal Cord Disease Incomplete Spinal Cord Injury Quadriplegia Tetraplegia SCI Spinal Cord Injury	iSCI Transcranial Direct Current Stimulation tDCS SCI recovery brain stimulation rehabilitation

Additional relevant MeSH terms:


Spinal Cord Injuries Quadriplegia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases	Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016