Overview

This trial is active, not recruiting.

Condition stroke
Treatment transcranial stimulation
Phase phase 2
Sponsor Spaulding Rehabilitation Hospital
Start date April 2010
End date April 2011
Trial size 120 participants
Trial identifier NCT01143649, 2009p001808

Summary

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
transcranial stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
(Experimental)
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active tDCS stimulation will be randomized. Each stimulation day will include up to six hours of training termed "shaping" in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of either real tDCS at 1mA or sham tDCS.
transcranial stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
(Active Comparator)
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized.
transcranial stimulation
Subjects will be stimulated at 1 mA for 40 minutes.

Primary Outcomes

Measure
Motor function
time frame: 2 weeks

Secondary Outcomes

Measure
Cortical excitability
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: All subjects must be between the ages of 18-90 and must not be pregnant. Additional Entry criteria for Stroke subject enrollment: 1. First-time clinical ischemic or hemorrhagic cerebrovascular accident - 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. Significant pre-stroke disability; 2. Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke); 3. Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing; 4. Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects); 5. Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants - history of seizures - unexplained loss of consciousness - metal in the head - frequent or severe headaches or neck pain - implanted brain medical devices. 6. Contraindications to tDCS - metal in the head - implanted brain medical devices 7. Advanced liver, kidney, cardiac, or pulmonary disease; 8. A terminal medical diagnosis consistent with survival < 1 year; 9. Coexistent major neurological or psychiatric disease as to decrease number of confounders; 10. A history of significant alcohol or drug abuse in the prior 6 months; 11. Use of carbamazepine and amitriptyline; 12. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and 13. Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke; 14. History of epilepsy before stroke (or episodes of seizures within the last six months). 15. Subjects with global aphasia and deficits of comprehension 16. Pregnancy

Additional Information

Official title Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Principal investigator Felipe Fregni, PhD
Description More study details will be provided by Spaulding Rehabilitation Hospital.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.