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

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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Healthy
Interventions: Device: transcranial direct current stimulation (tDCS)
Procedure: constraint induced movement therapy (CIMT)
Device: transcranial alternating current stimulation (tACS)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
tDCS + CIMT - Stroke

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).

Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes.

Sham tDCS + CIMT - Stroke

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).

Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment.

Healthy Participants: Active tDCS + Motor Training 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 tDCS at 1mA.
Healthy Participants: Sham tDCS + Motor Training 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 sham tDCS.
Healthy Participants - Active tACS, Then Sham Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.
Healthy Participants - Sham tACS, Then Active Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.

Participant Flow:   Overall Study
    tDCS + CIMT - Stroke   Sham tDCS + CIMT - Stroke   Healthy Participants: Active tDCS + Motor Training   Healthy Participants: Sham tDCS + Motor Training   Healthy Participants - Active tACS, Then Sham   Healthy Participants - Sham tACS, Then Active
STARTED   7   7   10   10   5   5 
COMPLETED   7   7   10   10   4   3 
NOT COMPLETED   0   0   0   0   1   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
tDCS + CIMT - Stroke

Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).

Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes.

Sham tDCS + CIMT - Stroke Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
tDCS Active + CIMT - Healthy Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
Sham tDCS + CIMT - Healthy Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
tACS Active&Sham - Healthy active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.
Total Total of all reporting groups

Baseline Measures
   tDCS + CIMT - Stroke   Sham tDCS + CIMT - Stroke   tDCS Active + CIMT - Healthy   Sham tDCS + CIMT - Healthy   tACS Active&Sham - Healthy   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   10   10   10   44 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      6  85.7%      10 100.0%      10 100.0%      10 100.0%      43  97.7% 
>=65 years      0   0.0%      1  14.3%      0   0.0%      0   0.0%      0   0.0%      1   2.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (12.8)   50.8  (14.9)   20.4  (1.7)   20.4  (1.7)   35.83  (18.65)   35.75  (11.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      4  57.1%      5  71.4%      7  70.0%      7  70.0%      4  40.0%      27  61.4% 
Male      3  42.9%      2  28.6%      3  30.0%      3  30.0%      6  60.0%      17  38.6% 


  Outcome Measures

1.  Primary:   Jebsen Taylor Hand Function Test   [ Time Frame: 2 weeks ]

2.  Primary:   Cortical Excitability   [ Time Frame: 1 hour ]

3.  Primary:   Cortical Oscillations - EEG   [ Time Frame: 15 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  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.


Results Point of Contact:  
Name/Title: Dr. Felipe Fregni
Organization: Laboratory of Neuromodulation and Center of Clinical Research Training. Spaulding Rehabilitation Hospital.
phone: 617.952.6153
e-mail: info@neuromodulationlab.org



Responsible Party: Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143649     History of Changes
Other Study ID Numbers: 2009p001808
First Submitted: April 20, 2010
First Posted: June 14, 2010
Results First Submitted: August 27, 2014
Results First Posted: March 6, 2017
Last Update Posted: April 17, 2017