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

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

Sponsors

Lead sponsor: Spaulding Rehabilitation Hospital

Source 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.

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.

Overall Status Completed
Start Date April 2010
Completion Date January 2016
Primary Completion Date April 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Jebsen Taylor Hand Function Test 2 weeks
Cortical Excitability 1 hour
Cortical Oscillations - EEG 15 minutes
Enrollment 44
Condition
Intervention

Intervention type: Device

Intervention name: transcranial direct current stimulation (tDCS)

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

Intervention type: Procedure

Intervention name: constraint induced movement therapy (CIMT)

Intervention type: Device

Intervention name: transcranial alternating current stimulation (tACS)

Description: Subjects will be stimulated at 15Hz for 20 minutes.

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:

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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Felipe Fregni, PhD Principal Investigator Spaulding Rehabilitation Hospital
Location
facility
Spaulding Rehabilitation Hospital
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Spaulding Rehabilitation Hospital

Investigator full name: Felipe Fregni

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Arm group label: active tDCS + CIMT - stroke patients

Arm group type: Experimental

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 group label: active tDCS + CIMT - Healthy

Arm group type: Experimental

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 group label: tACS - Healthy Subjects

Arm group type: Experimental

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 group label: sham tDCS + CIMT - stroke patients

Arm group type: Sham Comparator

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 group label: sham tDCS + CIMT - Healthy

Arm group type: Sham Comparator

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 group label: sham tACS - Healthy Subjects

Arm group type: Sham Comparator

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.

Acronym tdcs
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov