Overview

This trial is active, not recruiting.

Conditions stroke, motor function
Treatments repetitive transcranial magnetic stimulation (rtms), transcranial direct current stimulation (tdcs)
Phase phase 1
Sponsor Spaulding Rehabilitation Hospital
Start date May 2011
End date April 2017
Trial size 26 participants
Trial identifier NCT01574989, 2010-p-001461

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose basic science
Arm
(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.
repetitive transcranial magnetic stimulation (rtms) magnetic stimulation; Magstim
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.
transcranial direct current stimulation (tdcs) 1x1 low-intensity direct current stimulator; Soterix Medical
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.
(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.
repetitive transcranial magnetic stimulation (rtms) magnetic stimulation; Magstim
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.
transcranial direct current stimulation (tdcs) 1x1 low-intensity direct current stimulator; Soterix Medical
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.
(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.
repetitive transcranial magnetic stimulation (rtms) magnetic stimulation; Magstim
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.
transcranial direct current stimulation (tdcs) 1x1 low-intensity direct current stimulator; Soterix Medical
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.
(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.
repetitive transcranial magnetic stimulation (rtms) magnetic stimulation; Magstim
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.
transcranial direct current stimulation (tdcs) 1x1 low-intensity direct current stimulator; Soterix Medical
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.
(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.
repetitive transcranial magnetic stimulation (rtms) magnetic stimulation; Magstim
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.
transcranial direct current stimulation (tdcs) 1x1 low-intensity direct current stimulator; Soterix Medical
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.

Primary Outcomes

Measure
Changes in cortical excitability measures
time frame: Measured for approximately 6 weeks

Secondary Outcomes

Measure
Changes in motor function
time frame: Measured for approximately 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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;

Additional Information

Official title Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
Principal investigator Felipe Fregni, MD PHD MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.