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Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient (tdcs)
This study is ongoing, but not recruiting participants.

First Received on April 20, 2010.   Last Updated on September 12, 2011   History of Changes
Sponsor: Spaulding Rehabilitation Hospital
Information provided by (Responsible Party): Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143649
  Purpose

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.


Condition Intervention Phase
Stroke
Device: Transcranial Stimulation
Phase 2

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: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Motor function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The motor function assessment will be done with: The Jebsen Taylor Hand Function Test, Motor Activity Log Rating Scale, Fugl Meyer Assessment of Motor Recovery, Barthel Index Score (Activities of Daily Living).


Secondary Outcome Measures:
  • Cortical excitability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The investigators will investigate changes in cortical excitability evaluating the motor evoked potential (MEP) and the resting motor threshold (MT), intracortical excitability using the technique of paired-pulse and also transcallosal inhibition to measure interhemispheric differences.


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS + CIMT
Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
Experimental: tDCS + motor training- Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active tDCS stimulation will be randomized. Each stimulation day will include up to six hours of training termed "shaping" in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of either real tDCS at 1mA or sham tDCS.
Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
Active Comparator: tACS - Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized.
Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.

Detailed Description:

More study details will be provided by Spaulding Rehabilitation Hospital.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must be between the ages of 18-90 and must not be pregnant.

Additional Entry criteria for Stroke subject enrollment:

  1. First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;
  2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
  3. Stroke onset >6 months prior to study enrollment.

Exclusion Criteria:

  1. Significant pre-stroke disability;
  2. Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);
  3. Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;
  4. Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);
  5. Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants

    • history of seizures
    • unexplained loss of consciousness
    • metal in the head
    • frequent or severe headaches or neck pain
    • implanted brain medical devices.
  6. Contraindications to tDCS

    • metal in the head
    • implanted brain medical devices
  7. Advanced liver, kidney, cardiac, or pulmonary disease;
  8. A terminal medical diagnosis consistent with survival < 1 year;
  9. Coexistent major neurological or psychiatric disease as to decrease number of confounders;
  10. A history of significant alcohol or drug abuse in the prior 6 months;
  11. Use of carbamazepine and amitriptyline;
  12. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and
  13. Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke;
  14. History of epilepsy before stroke (or episodes of seizures within the last six months).
  15. Subjects with global aphasia and deficits of comprehension
  16. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143649

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143649     History of Changes
Other Study ID Numbers: 2009p001808
Study First Received: April 20, 2010
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Stroke
Transcranial direct current stimulation
Motor function

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2012