Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Adrian Guggisberg
- Enrollment
- 36
- Locations
- 4
- Primary Endpoint
- Change in upper extremity Fugl-Meyer score, after intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in upper extremity Fugl-Meyer score, after intervention
Time Frame: Difference between the week before the intervention and the week after intervention
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Secondary Outcomes
- Change in EEG functional connectivity, after intervention(Difference between the week before the intervention and the week after intervention)
- Change in amplitude of motor evoked potentials, after intervention(Difference between the week before the intervention and the week after intervention)
Investigators
Adrian Guggisberg
Médecin adjoint agrégé, assistant professor
University Hospital, Geneva