Effects of rTMS and tDCS on Motor Function in Stroke
Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started May 2011
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedApril 24, 2020
April 1, 2020
3.5 years
February 8, 2012
April 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in motor function
Measured for approximately 6 weeks
Study Arms (5)
Active low-frequency rTMS/sham tDCS
EXPERIMENTALSubjects 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.
Active high-frequency rTMS/sham tDCS
EXPERIMENTALSubjects 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.
Sham rTMS/active anodal tDCS
EXPERIMENTALSubjects 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.
Sham rTMS/active cathodal tDCS
EXPERIMENTALSubjects 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.
Sham rTMS/Sham tDCS
SHAM COMPARATORSubjects 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- (1) All subjects must be between the ages of 18-90.
You may not qualify if:
- 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;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD PHD MPH
Spaulding Rehabilitation Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 8, 2012
First Posted
April 10, 2012
Study Start
May 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
April 24, 2020
Record last verified: 2020-04