TDCS+OT: Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00792428
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 80.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Cerebrovascular Accident; CVA; Acute Stroke; Acute Cerebrovascular Accident; Apoplexy	Device: Real Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Facilitating Motor Recovery After Stroke Using tDCS
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Real-tDCS + PT-OT Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.	Device: Real Transcranial Direct Current Stimulation; A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue; Other Names: Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery
Sham Comparator: Sham-tDCS + PT-OT Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.	Device: Sham Transcranial Direct Current Stimulation; A sham current runs between two electrode positions and might affect the underlying brain tissue.; Other Names: Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment of Upper Extremity Motor Impairment [Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days]

   This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.

Secondary Outcome Measures

1. Wolf-Motor-Function-Test [Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days]

   The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• First time clinical ischemic stroke or cerebrovascular accident

• At least 5 months out from first ischemic stroke prior to study enrollment

Exclusion Criteria:

• More than 1 stroke (older strokes)

• Significant pre-stroke disability

• A terminal medical illness or disorder with survival of less than 1 year

• Co-existent major neurological or psychiatric diseases (e.g., epilepsy)

• Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents

• Active participation in other stroke recovery trials testing interventions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center / Harvard Medical School	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Gottfried Schlaug, MD, PhD, Beth Israel Deaconess Medical Center / Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

• Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. Epub 2006 Oct 27.
• Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103.
• Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73. doi: 10.1111/j.1460-9568.2008.06459.x.
• Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4.

• Responsible Party: Gottfried Schlaug, Associate Professor of Neurology; Staff Neurologist, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00792428
• Other Study ID Numbers: 2005P000346; R01NS045049
• First Posted: Nov 18, 2008
• Last Update Posted: Jun 4, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gottfried Schlaug, Associate Professor of Neurology; Staff Neurologist, Beth Israel Deaconess Medical Center: Stroke; Ischemia; Infarction; Cerebrovascular Disorder; Central Nervous System Diseases; Brain Infarction; Brain Ischemia; Rehabilitation; Recovery; Neurorehabilitation; Plasticity
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Recruitment Details	We advertised in local media, on Craig's list, and informed neurology colleagues and rehabilitation specialists about our trial. Stroke patients had to be at least 5 months out from their stroke and had to have a moderate impairment in their upper extremity weakness.
Pre-assignment Detail	There were no significant events that occurred after participant enrollment, prior to assignment.

Arm/Group Title	Real-tDCS + PT-OT	Sham-tDCS + PT-OT
Arm/Group Description	Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue	Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Real-tDCS + PT-OT	Sham-tDCS + PT-OT	Total
Arm/Group Description	Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue	Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (14.7)	55.8 (12.9)	58.7 (13.8)
Sex: Female, Male (Count of Participants)
Female	2 20%	3 30%	5 25%
Male	8 80%	7 70%	15 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	10 100%	10 100%	20 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Description	This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Time Frame	Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Real-tDCS + PT-OT	Sham-tDCS + PT-OT
Arm/Group Description	Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.	Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
Measure Participants	10	10
Pre-treatment (Baseline)	38.2 (13.3)	39.8 (11.5)
Post-treatment1 (3 days after 5 days of treatment)	43.8 (12.3)	41.0 (11.8)
Post-treatment2 (7 days after 5 days of treatment)	44.3 (11.5)	40.9 (11.7)

2. Secondary Outcome

Title	Wolf-Motor-Function-Test
Description	The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.
Time Frame	Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Real-tDCS + PT-OT	Sham-tDCS + PT-OT
Arm/Group Description	Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.	Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
Measure Participants	10	10
Pre-treatment (baseline)	0.87 (0.55)	0.83 (0.48)
Post-treatment1 (3 days after 5 days of treatment)	0.74 (0.49)	0.79 (0.47)
Post-treatment2 (7 days after 5 days of treatment)	0.73 (0.49)	0.78 (0.46)

Adverse Events

Time Frame	Over the 5 days of experimental treatment and during the 1 week follow-up.
Arm/Group Title	Real-tDCS + PT-OT		Sham tDCS + PT-OT
Arm/Group Description	Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.		Subjects are receiving sham tDCS in a dual configuration over both motor regions for 30 minutes while they are also receiving PT-OT for 60 minutes
All Cause Mortality
	Real-tDCS + PT-OT		Sham tDCS + PT-OT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Real-tDCS + PT-OT		Sham tDCS + PT-OT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Real-tDCS + PT-OT		Sham tDCS + PT-OT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.