ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient (tdcs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01143649
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : March 6, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Stroke Healthy Device: transcranial direct current stimulation (tDCS) Procedure: constraint induced movement therapy (CIMT) Device: transcranial alternating current stimulation (tACS) Not Applicable

Detailed Description:

In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment on tACS uses a crossover design (exp 3).

For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Actual Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: active tDCS + CIMT - stroke patients
Participants will receive 5 sessions of 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 direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.

Procedure: constraint induced movement therapy (CIMT)
Experimental: active tDCS + CIMT - Healthy
Participants will receive one session of 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)
Device: transcranial direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.

Procedure: constraint induced movement therapy (CIMT)
Experimental: tACS - Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).
Device: transcranial alternating current stimulation (tACS)
Subjects will be stimulated at 15Hz for 20 minutes.

Sham Comparator: sham tDCS + CIMT - stroke patients
Participants will receive 5 sessions of 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). For the sham session, tDCS is turned off after 30seconds.
Device: transcranial direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.

Procedure: constraint induced movement therapy (CIMT)
Sham Comparator: sham tDCS + CIMT - Healthy
Participants will receive one session of 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). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.
Device: transcranial direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.

Procedure: constraint induced movement therapy (CIMT)
Sham Comparator: sham tACS - Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.
Device: transcranial alternating current stimulation (tACS)
Subjects will be stimulated at 15Hz for 20 minutes.




Primary Outcome Measures :
  1. Jebsen Taylor Hand Function Test [ Time Frame: 2 weeks ]
    Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.

  2. Cortical Excitability [ Time Frame: 1 hour ]

    Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham).

    The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison.


  3. Cortical Oscillations - EEG [ Time Frame: 15 minutes ]
    Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143649     History of Changes
Other Study ID Numbers: 2009p001808
First Posted: June 14, 2010    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017

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

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