Clinical trial NCT03635008: Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients
Official title: Effects of Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients With Severe Upper Extremity Hemiparesis: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Transcranial Direct Current Stimulation
Recovery of Function
Neurological Rehabilitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)
First posted: 2018-08-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, sham-controlled, parallel group design
Primary purpose: TREATMENT

Brief summary: Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.

In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (\<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.


Eligibility criteria: Inclusion Criteria:

* Age: 18-85 years old
* Ischemic or Hemorrhagic stroke confirmed by the MRI or CT
* First-ever stroke
* \< 3 months after stroke
* Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under 25. (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,

Exclusion Criteria:

* recurrent stroke
* history of the other brain injury (e.g. traumatic brain injury)
* poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).
* Poor cooperation due to delirium or problems in the consciousness
* Uncontrolled or unstable medical conditions.
* Pregnant
* Scalp problems which interfere with the tDCS application
* Robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain.
* Metals in the head (e.g. clip, coil)
* Cardiac pacemaker or cochlear implants

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA) scores of the upper extremity
timeFrame: Change from Baseline FMA at 2 weeks
Secondary outcomes:
measure: Korean version of modified Barthel Index (K-MBI)
timeFrame: Change from baseline K-MBI at 2 weeks
measure: Korean version of modified Barthel Index (K-MBI)
timeFrame: Change from baseline K-MBI at 6 weeks
measure: Brunnstrom stage (B-stage) of arm
timeFrame: Change from baseline B-stage at 2 weeks
measure: Brunnstrom stage (B-stage) of arm
timeFrame: Change from baseline B-stage at 6 weeks
measure: Box and Block Test (BBT)
timeFrame: Change from baseline BBT at 2 weeks
measure: Box and Block Test (BBT)
timeFrame: Change from baseline BBT at 6 weeks
measure: Modified Ashworth Scale
timeFrame: 2 weeks after baseline
measure: Modified Ashworth Scale
timeFrame: 6 weeks after baseline
measure: Manual muscle power test
timeFrame: 2 weeks after baseline
measure: Manual muscle power test
timeFrame: 6 weeks after baseline
measure: Laterality Index
timeFrame: 2 weeks after baseline
measure: Laterality Index
timeFrame: 6 weeks after baseline
measure: Fugl-Meyer Assessment (FMA) scores of the upper extremity
timeFrame: Change from Baseline FMA at 6 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Please Select
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Won-Seok Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: