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Clinical Trials/NCT03342534
NCT03342534
Terminated
Not Applicable

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke

Adrian Guggisberg2 sites in 1 country36 target enrollmentNovember 13, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Adrian Guggisberg
Enrollment
36
Locations
2
Primary Endpoint
Change in upper extremity Fugl-Meyer score, after intervention
Status
Terminated
Last Updated
10 months ago

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2017
End Date
September 30, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Adrian Guggisberg

Médecin adjoint agrégé, assistant professor

University Hospital, Geneva

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

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)

Study Sites (2)

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