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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active low-frequency rTMS/sham tDCS | Experimental | 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. |
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| Active high-frequency rTMS/sham tDCS | Experimental | 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. |
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| Sham rTMS/active anodal tDCS | Experimental | 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. |
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| Sham rTMS/active cathodal tDCS | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 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. |
| 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 |
| 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 |
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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
Contraindications to tDCS
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:
Additional exclusion criteria for stroke subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD PHD MPH | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D003295 | Convulsive Therapy |
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| Sham rTMS/Sham tDCS | Sham Comparator | 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. |
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| Transcranial Direct Current Stimulation (tDCS) | Device | 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. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013000 |
| Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |