Effects of rTMS and tDCS on Motor Function in Stroke
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ClinicalTrials.gov Identifier: NCT01574989 |
Recruitment Status
:
Completed
First Posted
: April 10, 2012
Last Update Posted
: April 25, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Motor Function | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Transcranial Direct Current Stimulation (tDCS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |
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 Name: magnetic stimulation; Magstim
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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical
|
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 Name: magnetic stimulation; Magstim
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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical
|
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 Name: magnetic stimulation; Magstim
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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical
|
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 Name: magnetic stimulation; Magstim
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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical
|
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 Name: magnetic stimulation; Magstim
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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical
|
- Changes in cortical excitability measures [ Time Frame: 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.
- Changes in motor function [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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;
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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.
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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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574989
United States, Massachusetts | |
Spaulding Rehabilitation Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Felipe Fregni, MD PHD MPH | Spaulding Rehabilitation Hospital |
Responsible Party: | Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital |
ClinicalTrials.gov Identifier: | NCT01574989 History of Changes |
Other Study ID Numbers: |
2010-p-001461 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | April 25, 2017 |
Last Verified: | April 2016 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
direct current stimulation magnetic stimulation transcranial stimulation |
Additional relevant MeSH terms:
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |