Effects of rTMS and tDCS on Motor Function in Stroke

Mass General Brigham

Status: Completed

Conditions: Stroke; Motor Function

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01574989

2010-p-001461

Details and patient eligibility

About

In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

(1) All subjects must be between the ages of 18-90.

Exclusion criteria

1. History of Major depression, as defined by Beck Depression scale 30;

2. Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;

3. Contraindications to TMS

   • history of seizures
   • unexplained loss of consciousness
   • metal in the head
   • frequent or severe headaches or neck pain
   • implanted brain medical devices.

4. Contraindications to tDCS

   • metal in the head
   • implanted brain medical devices

5. Advanced liver, kidney, cardiac, or pulmonary disease;

6. A terminal medical diagnosis consistent with survival < 1 year;

7. Coexistent major neurological or psychiatric disease (to decrease number of confounders);

8. A history of significant alcohol or drug abuse in the prior 6 months;

9. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;

10. Subjects with global aphasia and deficits of comprehension

11. Pregnancy. Female subjects of child bearing potential will be asked to take a pregnancy test. If the pregnancy test is positive, the subject may not enroll in the study.

12. Use of neuropsychotropic medications [healthy subjects only]

Additional inclusion criteria for stroke subjects:

1. First-time clinical ischemic or hemorrhagic cerebrovascular events - 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 .

Additional exclusion criteria for stroke subjects:

1. Subjects may not have already received TMS and/or tDCS stimulation for stroke;
2. History of epilepsy before stroke or episodes of seizures within the last six months;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 5 patient groups

Active low-frequency rTMS/sham tDCS

Experimental group

Description:

Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, low-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Active high-frequency rTMS/sham tDCS

Experimental group

Description:

Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, high-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS/active anodal tDCS

Experimental group

Description:

Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, anodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS/active cathodal tDCS

Experimental group

Description:

Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, cathodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS/Sham tDCS

Sham Comparator group

Description:

Subjects will have both the rTMS and tDCS on their scalp during the session, and both interventions will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)