Effects of rTMS and tDCS on Motor Function in Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients

Conditions
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Stroke, Motor Function

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Device: Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: (1) All subjects must be between the ages of 18-90. Exclusion criteria: History of Major depression, as defined by Beck Depression scale 30; Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing; 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. 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 (to decrease number of confounders); A history of significant alcohol or drug abuse in the prior 6 months; Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials; Subjects with global aphasia and deficits of comprehension 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. Use of neuropsychotropic medications [healthy subjects only] Additional inclusion criteria for stroke subjects: First-time clinical ischemic or hemorrhagic cerebrovascular events - 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 . Additional exclusion criteria for stroke subjects: Subjects may not have already received TMS and/or tDCS stimulation for stroke; History of epilepsy before stroke or episodes of seizures within the last six months;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active low-frequency rTMS/sham tDCS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.<br>* Other names: magnetic stimulation; Magstim;Device: Transcranial Direct Current Stimulation (tDCS)<br>* Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.<br>* Other names: 1x1 low-intensity direct current stimulator; Soterix Medical;|
| Experimental: Active high-frequency rTMS/sham tDCS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.<br>* Other names: magnetic stimulation; Magstim;Device: Transcranial Direct Current Stimulation (tDCS)<br>* Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.<br>* Other names: 1x1 low-intensity direct current stimulator; Soterix Medical;|
| Experimental: Sham rTMS/active anodal tDCS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.<br>* Other names: magnetic stimulation; Magstim;Device: Transcranial Direct Current Stimulation (tDCS)<br>* Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.<br>* Other names: 1x1 low-intensity direct current stimulator; Soterix Medical;|
| Experimental: Sham rTMS/active cathodal tDCS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.<br>* Other names: magnetic stimulation; Magstim;Device: Transcranial Direct Current Stimulation (tDCS)<br>* Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.<br>* Other names: 1x1 low-intensity direct current stimulator; Soterix Medical;|
| Sham Comparator: Sham rTMS/Sham tDCS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.<br>* Other names: magnetic stimulation; Magstim;Device: Transcranial Direct Current Stimulation (tDCS)<br>* Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.<br>* Other names: 1x1 low-intensity direct current stimulator; Soterix Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortical excitability measures | We will measure cortical excitability using single- and paired-pulse transcranial magnetic stimulation (TMS) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS. | Measured for approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in motor function | We will measure motor function using behavioral tasks (ex. purdue pegboard, jebsen taylor test, range of motion) both before and after the stimulation sessions. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS. | Measured for approximately 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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direct current stimulation, magnetic stimulation, transcranial stimulation