Effects of rTMS and tDCS on Motor Function in Stroke

Stroke Clinical Trial

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574989
• Other study ID #: 2010-p-001461
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Motor Function
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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