Clinical trial NCT02308852: Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Deficit in Manual Activities
Keywords: bi-manual , motor skill learning , stroke , chronic patients,neuro-rehabilitative robot
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: tDCS real versus sham tDCS (this is what this is)
Primary purpose: TREATMENT

Brief summary: Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.

A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.

Detailed description: tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in chronic stroke patients with motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during performance of bimanual activities and/or motor learning. A few minutes/hours/days/weeks after completing one trial's arm, the patients will enter the other trial's arm (double-blind cross-over design).

Baseline and follow-up outcomes about bimanual and unimanual motor tasks will be collected.

For a subset of subjects, motor learning and data acquisition will be performed with a neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) .

Eligibility criteria: Inclusion Criteria:

• stroke with at least slight deficit

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand / complete behavioral tasks
* chronic intake of alcohol or recreational drugs
* major health condition
* presence of pacemaker (for the fMRI part only)
* pregnancy

Primary outcomes:
measure: bimanual coordination
timeFrame: up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention
Secondary outcomes:
measure: standard unimanual evaluation
timeFrame: immediately, 30, 60 min; and up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention)
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: University Hospital CHU Dinant Godinne UcL Namur
Study officials:
References:
citation: De Laet C, Herman B, Riga A, Bihin B, Regnier M, Leeuwerck M, Raymackers JM, Vandermeeren Y. Bimanual motor skill learning after stroke: Combining robotics and anodal tDCS over the undamaged hemisphere: An exploratory study. Front Neurol. 2022 Aug 18;13:882225. doi: 10.3389/fneur.2022.882225. eCollection 2022.
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.