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Effects of rTMS and tDCS on Motor Function in Stroke

Primary Purpose

Stroke, Motor Function

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring direct current stimulation, magnetic stimulation, transcranial stimulation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Active low-frequency rTMS/sham tDCS

Active high-frequency rTMS/sham tDCS

Sham rTMS/active anodal tDCS

Sham rTMS/active cathodal tDCS

Sham rTMS/Sham tDCS

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 8, 2012
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01574989
Brief Title
Effects of rTMS and tDCS on Motor Function in Stroke
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Function
Keywords
direct current stimulation, magnetic stimulation, transcranial stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active low-frequency rTMS/sham tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Active high-frequency rTMS/sham tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS/active anodal tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS/active cathodal tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS/Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Intervention Name(s)
magnetic stimulation; Magstim
Intervention Description
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
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
1x1 low-intensity direct current stimulator; Soterix Medical
Intervention Description
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 Outcome Measure Information:
Title
Changes in cortical excitability measures
Description
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.
Time Frame
Measured for approximately 6 weeks
Secondary Outcome Measure Information:
Title
Changes in motor function
Description
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.
Time Frame
Measured for approximately 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; 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; 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PHD MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
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.
Results Reference
derived

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Effects of rTMS and tDCS on Motor Function in Stroke

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