Clinical trial NCT01007136: Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery
Official title: TDCS-enhanced Stroke Recovery and Cortical Reorganization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Stroke
Keywords: tDCS
stroke
functional MRI
TMS
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-11-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.


Eligibility criteria: Inclusion Criteria:

* ischemic stroke causing arm weakness within 5-15 days
* no other neurological or psychiatric disease, who are able to perform study tasks

Exclusion Criteria:

* patients younger than 18 or older than 80 years
* patients with more than one disabling stroke
* Patients with bilateral motor impairment
* Patients with poor motivational capacity, history of severe alcohol or drug abuse
* Patients with severe language disturbances, particularly of receptive nature
* Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
* Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
* Patients with unstable thyroid disease
* Patients with increased intracranial pressure
* Patients with unstable cardiac arrhythmia
* Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
* Patients who are not available for follow-up at 3 and 12 months
* Pregnancy
* Patients with contraindication to MRI will not participate in MRI

Primary outcomes:
measure: Upper Extremity Fugl-Meyer
timeFrame: 2 weeks
measure: Upper Extremity Fugl-Meyer
timeFrame: 3 months
measure: Upper Extremity Fugl-Meyer
timeFrame: 1 year after stroke
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: 3 months
Other outcomes:
measure: Visual Analog Pain Scale
timeFrame: during therapy
measure: Mini Mental Status Scale
timeFrame: 3 months
measure: NIHSS
timeFrame: 3 months
measure: Beck Depression Inventory
timeFrame: 3 months
measure: Ashworth Spasticity Scale
timeFrame: 3 months
measure: Abilhand Questionnaire
timeFrame: 3 months
measure: Motor Activity Log
timeFrame: 3 months
measure: fMRI Overactivation in Motor Cortex: Voxel Count and Intensity
timeFrame: 3 months
measure: Barthel Index
timeFrame: 3 months
measure: Medical Research Council (MRC) Scale
timeFrame: 3 months
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
citation: Hidler J, Hodics T, Xu B, Dobkin B, Cohen LG. MR compatible force sensing system for real-time monitoring of wrist moments during fMRI testing. J Neurosci Methods. 2006 Sep 15;155(2):300-7. doi: 10.1016/j.jneumeth.2006.01.016. Epub 2006 Feb 21.
citation: Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012 Nov;93(11):1963-7. doi: 10.1016/j.apmr.2012.05.002. Epub 2012 May 10.
citation: Hodics T, Cohen LG, Pezzullo JC, Kowalske K, Dromerick AW. Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population. Neurorehabil Neural Repair. 2022 Sep;36(9):596-602. doi: 10.1177/15459683221088861. Epub 2022 Aug 4.
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.