Clinical trial NCT01574989: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Motor Function
Keywords: direct current stimulation
magnetic stimulation
transcranial stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Changes in cortical excitability measures
timeFrame: Measured for approximately 6 weeks
Secondary outcomes:
measure: Changes in motor function
timeFrame: Measured for approximately 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PHD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.