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

Not Applicable

Completed

• Conditions: Stroke; Healthy

• Registration Number: NCT01143649
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-04
• Results First Submitted: 2014-08-27
• Study Completion: 2016-01
• Results First Submitted QC: 2017-03-01
• Results First Posted: 2017-03-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Jebsen Taylor Hand Function Test	2 weeks	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 Oscillations - EEG	15 minutes	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.
Cortical Excitability	1 hour	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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States