Effects of rTMS and tDCS on Motor Function in Stroke
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active low-frequency rTMS/sham tDCS 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)
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.
Other Names:
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
|
| Experimental: Active high-frequency rTMS/sham tDCS 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)
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.
Other Names:
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
|
| Experimental: Sham rTMS/active anodal tDCS 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)
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.
Other Names:
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
|
| Experimental: Sham rTMS/active cathodal tDCS 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)
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.
Other Names:
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
|
| Sham Comparator: Sham rTMS/Sham tDCS 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)
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.
Other Names:
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in cortical excitability measures [Measured for approximately 6 weeks]
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.
Secondary Outcome Measures
- Changes in motor function [Measured for approximately 6 weeks]
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.
Eligibility Criteria
Criteria
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;
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Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;
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Contraindications to TMS
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history of seizures
-
unexplained loss of consciousness
-
metal in the head
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frequent or severe headaches or neck pain
-
implanted brain medical devices.
- Contraindications to tDCS
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metal in the head
-
implanted brain medical devices
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Advanced liver, kidney, cardiac, or pulmonary disease;
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A terminal medical diagnosis consistent with survival < 1 year;
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Coexistent major neurological or psychiatric disease (to decrease number of confounders);
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A history of significant alcohol or drug abuse in the prior 6 months;
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Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;
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Subjects with global aphasia and deficits of comprehension
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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.
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Use of neuropsychotropic medications [healthy subjects only]
Additional inclusion criteria for stroke subjects:
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First-time clinical ischemic or hemorrhagic cerebrovascular events - evidenced by a radiological (or physician's) report
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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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spaulding Rehabilitation Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Spaulding Rehabilitation Hospital
Investigators
- Principal Investigator: Felipe Fregni, MD PHD MPH, Spaulding Rehabilitation Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-p-001461