Overview

This trial has been completed.

Conditions stroke, healthy
Treatments transcranial direct current stimulation (tdcs), constraint induced movement therapy (cimt), transcranial alternating current stimulation (tacs)
Phase phase 2
Sponsor Spaulding Rehabilitation Hospital
Start date April 2010
End date April 2011
Trial size 44 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
Intervention model parallel assignment
Primary purpose treatment
Masking participant, outcomes assessor
Arm
(Experimental)
Participants will receive 5 sessions of 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 direct current stimulation (tdcs)
Subjects will be stimulated at 1 mA for 40 minutes.
constraint induced movement therapy (cimt)
(Experimental)
Participants will receive one session of 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)
transcranial direct current stimulation (tdcs)
Subjects will be stimulated at 1 mA for 40 minutes.
constraint induced movement therapy (cimt)
(Experimental)
The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).
transcranial alternating current stimulation (tacs)
Subjects will be stimulated at 15Hz for 20 minutes.
(Sham Comparator)
Participants will receive 5 sessions of 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). For the sham session, tDCS is turned off after 30seconds.
transcranial direct current stimulation (tdcs)
Subjects will be stimulated at 1 mA for 40 minutes.
constraint induced movement therapy (cimt)
(Sham Comparator)
Participants will receive one session of 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). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.
transcranial direct current stimulation (tdcs)
Subjects will be stimulated at 1 mA for 40 minutes.
constraint induced movement therapy (cimt)
(Sham Comparator)
The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.
transcranial alternating current stimulation (tacs)
Subjects will be stimulated at 15Hz for 20 minutes.

Primary Outcomes

Measure
Jebsen Taylor Hand Function Test
time frame: 2 weeks
Cortical Excitability
time frame: 1 hour
Cortical Oscillations - EEG
time frame: 15 minutes

Eligibility Criteria

All 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 In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment on tACS uses a crossover design (exp 3). For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.