Effects of rTMS and tDCS on Motor Function in Stroke

NCT ID: NCT01574989

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Stroke; Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

magnetic stimulation; Magstim; 1x1 low-intensity direct current stimulator; Soterix Medical

Eligibility Criteria

Inclusion Criteria

(1) All subjects must be between the ages of 18-90.

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 .

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]

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD PHD MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

2010-p-001461

Identifier Type: -

Identifier Source: org_study_id