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Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308852
Enrollment
100
Registered
2014-12-04
Start date
2014-10-31
Completion date
2030-12-31
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficit in Manual Activities, Stroke

Keywords

bi-manual , motor skill learning , stroke , chronic patients,neuro-rehabilitative robot

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) .

Interventions

DEVICEtDCS

Sponsors

University Hospital of Mont-Godinne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

tDCS real versus sham tDCS (this is what this is)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
bimanual coordinationup to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the interventionThe effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.

Secondary

MeasureTime frameDescription
standard unimanual evaluationimmediately, 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)Performance on motor skill learning tasks and on different commonly used tasks (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT, motor skill learning with a videogame, ...) will be measured to explore the impact of tDCS on these parameters in chronic stroke patients.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026