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

Healthy Clinical Trial

— tdcs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143649
• Other study ID #: 2009p001808
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: January 2016

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Stroke

Intervention

Device:
• transcranial direct current stimulation (tDCS)
Subjects will be stimulated at 1 mA for 40 minutes.

Procedure:
• constraint induced movement therapy (CIMT)

Device:
• transcranial alternating current stimulation (tACS)
Subjects will be stimulated at 15Hz for 20 minutes.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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