search
Back to results

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

Primary Purpose

Stroke, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
constraint induced movement therapy (CIMT)
transcranial alternating current stimulation (tACS)
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial direct current stimulation, Motor function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Sham Comparator

Sham Comparator

Arm Label

active tDCS + CIMT - stroke patients

active tDCS + CIMT - Healthy

tACS - Healthy Subjects

sham tDCS + CIMT - stroke patients

sham tDCS + CIMT - Healthy

sham tACS - Healthy Subjects

Arm Description

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).

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 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).

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2010
Last Updated
April 22, 2020
Sponsor
Spaulding Rehabilitation Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01143649
Brief Title
Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient
Acronym
tdcs
Official Title
Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Healthy
Keywords
Stroke, Transcranial direct current stimulation, Motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS + CIMT - stroke patients
Arm Type
Experimental
Arm Description
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).
Arm Title
active tDCS + CIMT - Healthy
Arm Type
Experimental
Arm Description
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)
Arm Title
tACS - Healthy Subjects
Arm Type
Experimental
Arm Description
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).
Arm Title
sham tDCS + CIMT - stroke patients
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
sham tDCS + CIMT - Healthy
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
sham tACS - Healthy Subjects
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
Subjects will be stimulated at 1 mA for 40 minutes.
Intervention Type
Procedure
Intervention Name(s)
constraint induced movement therapy (CIMT)
Intervention Type
Device
Intervention Name(s)
transcranial alternating current stimulation (tACS)
Intervention Description
Subjects will be stimulated at 15Hz for 20 minutes.
Primary Outcome Measure Information:
Title
Jebsen Taylor Hand Function Test
Description
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.
Time Frame
2 weeks
Title
Cortical Excitability
Description
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.
Time Frame
1 hour
Title
Cortical Oscillations - EEG
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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. Exclusion Criteria: 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; Coexistent major neurological or psychiatric disease as to decrease number of confounders; A history of significant alcohol or drug abuse in the prior 6 months; Use of carbamazepine and amitriptyline; Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke; History of epilepsy before stroke (or episodes of seizures within the last six months). Subjects with global aphasia and deficits of comprehension Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs