Skip to main content
OpenTrials
Completed

NCT Number: NCT01574989

Effects of rTMS and tDCS on Motor Function in Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

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.

Other names: magnetic stimulation; Magstim

Transcranial direct current stimulation (tDCS)

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.

Other names: 1x1 low-intensity direct current stimulator; Soterix Medical

Primary outcomes

  1. Changes in cortical excitability measures

    Time frame: Measured for approximately 6 weeks

    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 outcomes

  1. Changes in motor function

    Time frame: Measured for approximately 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2012
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.