Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient
tdcs
Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Apr 2010
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedApril 24, 2020
April 1, 2020
1 year
April 20, 2010
August 27, 2014
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Jebsen Taylor Hand Function Test
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 weeks
Cortical Excitability
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.
1 hour
Cortical Oscillations - EEG
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.
15 minutes
Study Arms (6)
active tDCS + CIMT - stroke patients
EXPERIMENTALParticipants 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).
active tDCS + CIMT - Healthy
EXPERIMENTALParticipants 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)
tACS - Healthy Subjects
EXPERIMENTALThe 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).
sham tDCS + CIMT - stroke patients
SHAM COMPARATORParticipants 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.
sham tDCS + CIMT - Healthy
SHAM COMPARATORParticipants 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.
sham tACS - Healthy Subjects
SHAM COMPARATORThe 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.
Interventions
Subjects will be stimulated at 1 mA for 40 minutes.
Subjects will be stimulated at 15Hz for 20 minutes.
Eligibility Criteria
You may qualify if:
- All subjects must be between the ages of 18-90 and must not be pregnant.
- Additional Entry criteria for Stroke subject enrollment:
- First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;
- Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
- Stroke onset \>6 months prior to study enrollment.
You may not qualify if:
- Significant pre-stroke disability;
- Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;
- Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);
- 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.
- Contraindications to tDCS
- metal in the head
- implanted brain medical devices
- Advanced liver, kidney, cardiac, or pulmonary disease;
- A terminal medical diagnosis consistent with survival \< 1 year;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Felipe Fregni
- Organization
- Laboratory of Neuromodulation and Center of Clinical Research Training. Spaulding Rehabilitation Hospital.
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, PhD
Spaulding Rehabilitation Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 20, 2010
First Posted
June 14, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2011
Study Completion
January 1, 2016
Last Updated
April 24, 2020
Results First Posted
March 6, 2017
Record last verified: 2020-04