Clinical trial NCT02827864: Efficacy and Time Dependent Effects of tDCS Combined With MT for Rehabilitation After Subacute and Chronic Stroke
Official title: Efficacy and Time Dependent Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Mirror Therapy for Rehabilitation After Subacute and Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Mirror therapy
transcranial direct current stimulation
stroke
neurorehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.

Detailed description: This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.

Eligibility criteria: Inclusion Criteria:

1. experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;
2. UE-FMA score between 18 and 56
3. able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)

Exclusion Criteria:

1. Participants are currently involved in other rehabilitation or drug research trial(s);
2. have neurological or psychological disorders other than stroke;
3. have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;
4. received Botulinum toxin injections 3 months prior to enrollment
5. have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
6. have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body
7. have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: baseline, 1 month, 4 months
Secondary outcomes:
measure: Change scores of Adelaide Activities Profile (AAP)
timeFrame: baseline, 1 month
measure: Change scores of 10-Meter Walk Test (10MWT)
timeFrame: baseline, 1 month
measure: Change scores of Stroop test
timeFrame: baseline, 1 month
measure: Change scores of pressure pain threshold
timeFrame: baseline, 1 month
measure: Change scores of Dual-Task Block and Box Test
timeFrame: baseline, 1 month, 4 months
measure: Change scores of EuroQol (EQ)-5D questionnaire
timeFrame: baseline, 1 month
measure: Change scores of Pinch and grasp dynamometer
timeFrame: baseline, 1 month
measure: Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: baseline, 1 month
measure: Change scores of The Facial Pain Scale-Revised (FPS-R )
timeFrame: baseline, 1 month
measure: Change scores of Modified Rankin Scale (mRS)
timeFrame: baseline, 1 month
measure: Change scores of The short form of the Betts Questionnaire Upon Mental Imagery (Betts QMI)
timeFrame: baseline, 1 month
measure: Change scores of The Facial Fatigue Scale-Revised (FFS-R)
timeFrame: baseline, 1 month
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: baseline, 1 month
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: baseline, 1 month
measure: Change scores of MyotonPro
timeFrame: baseline, 1 month
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: baseline, 1 month
measure: Change scores of Motor Activity Log (MAL)
timeFrame: baseline, 1 month, 4 months
measure: Change scores of Actigraphy
timeFrame: baseline, 1 month
measure: Change scores of ABILHAND Questionnaire
timeFrame: baseline, 1 month, 4 months
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: baseline, 1 month
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: baseline, 1 month, 4 months
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: baseline, 1 month, 4 months
measure: Change scores of Functional Independence Measure (FIM)
timeFrame: baseline, 1 month
Other outcomes:
Locations:
city: Songshan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taipei
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Ching-Yi Wu
role: STUDY_CHAIR
References:
citation: Liao WW, Chiang WC, Lin KC, Wu CY, Liu CT, Hsieh YW, Lin YC, Chen CL. Timing-dependent effects of transcranial direct current stimulation with mirror therapy on daily function and motor control in chronic stroke: a randomized controlled pilot study. J Neuroeng Rehabil. 2020 Jul 20;17(1):101. doi: 10.1186/s12984-020-00722-1.