Clinical trial NCT03342534: Effect of tDCS on Brain Organization and Motor Recovery
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Clinique Romande de Readaptation
name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2017-11-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.

Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.

The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* ≤ 4 weeks after stroke onset
* Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
* Capable of participating during treatment sessions of 30-60 minutes
* Informed consent obtained

Exclusion Criteria:

* Incapacity to understand study information or task instructions during trial.
* New additional stroke during rehabilitation
* Reduced vigilance or delirium
* Severe language deficits
* Preexisting affection of an upper limb
* Severe spasticity or dystonia
* Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
* Pregnancy
* Pacemaker
* Skull breach
* History of seizures or epilepsy
* Metallic object in the brain
* Other contraindication to non-invasive brain stimulation

Primary outcomes:
measure: Change in upper extremity Fugl-Meyer score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
Secondary outcomes:
measure: Change in EEG functional connectivity, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in amplitude of motor evoked potentials, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
Other outcomes:
measure: Change in upper extremity Fugl-Meyer score, follow up 1
timeFrame: Difference between the week before intervention and 4 weeks after intervention
measure: Change in upper extremity Fugl-Meyer score, follow up 2
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Jamar dynamometer, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Jamar dynamometer, follow up 1
timeFrame: Difference between the week before intervention and 4 weeks after intervention
measure: Change in Jamar dynamometer, follow up 2
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Nine-Hole-Peg test, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Nine-Hole-Peg test, follow up 1
timeFrame: Difference between the week before intervention and 4 weeks after intervention
measure: Change in Nine-Hole-Peg test, follow up 2
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in action research arm test (ARAT) score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in action research arm test (ARAT) score, follow up 1
timeFrame: Difference between the week before intervention and 4 weeks after intervention
measure: Change in action research arm test (ARAT) score, follow up 2
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Functional Independence Measure (FIM) score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Functional Independence Measure (FIM) score, follow up 1
timeFrame: Difference between the week before intervention and 4 weeks after intervention
measure: Change in Functional Independence Measure (FIM) score, follow up 2
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
Locations:
city: Geneva
country: Switzerland
facility: Division of Neurorehabilitation, University Hospital of Geneva
state: GE
city: Bern
country: Switzerland
facility: Universitäre Neurorehabilitation, Inselspital
Study officials:
affiliation: University of Geneva
name: Adrian G Guggisberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas - Austin
name: José Millán, PhD
role: STUDY_DIRECTOR
References: