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Clinical Trials/NCT02101398
NCT02101398TerminatedNot Applicable

Etude de l'Effet de Stimulations transcrâniennes en Courant Continu (tDCS) Sur Les Performances en dénomination Chez le Sujet Aphasique à Moins d'un an de Son Accident Vasculaire cérébral : Comparaison de 5 Configurations de Stimulation

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country5 target enrollmentStarted: October 2, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
5
Locations
1
Primary Endpoint
Percentage of improvement of picture naming

Study Overview

Brief Summary

The aim of this work is to study the effect of transcranial direct current stimulation combined with naming therapy in acute and post-acute stroke comparing four bihemispheric positioning electrodes to a sham condition.

Detailed Description

TDCS have shown a positive effect on clinical outcome in naming treatment in aphasic subjects however some aspects as the positioning of the electrodes on the head are still unclear. That is why we compare the effects of four different positionings of the electrodes (two anterior over Broca's area and its homologue and two posterior over Wernicke's area and its homologue) to a sham stimulation in order to observe if a more important effect of one or another positioning could be found.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •man or woman of 18 years and older
  • •aphasic patient following a first left hemispheric stroke
  • •BDAE 3.0 aphasia score > or = to 1
  • •stroke within 3 to 12 months before inclusion in the study
  • •mother tongue = French
  • •right handedness
  • •signed informed consent

Exclusion Criteria

  • •history of other neurologic pathologies
  • •epileptic seizure within 2 months before inclusion
  • •bilingual patient (2 mother tongues)
  • •history of cranial surgery
  • •presence of intracerebral metallic material
  • •unauthorized molecules at inclusion : sulpiride, rivastigmine, dextromethorphan, carbamazepine, flunarizine, levodopa
  • •pregnant, parturient or lactating woman

Arms & Interventions

F7A

Experimental

Anodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation.

Intervention: eldith DC-stimulator, configuration F7A (Device)

F7C

Experimental

Cathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation.

Intervention: eldith DC-stimulator, configuration F7C (Device)

T5A

Experimental

Anodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation.

Intervention: eldith DC-stimulator, configuration T5A (Device)

T5C

Experimental

Cathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation.

Intervention: eldith DC-stimulator, configuration T5C (Device)

Sham

Sham Comparator

Electrodes set on the left Broca's area and its right homologue or electrodes set on the left Wernicke's area and its right homologue, but no stimulation will be delivered.

Intervention: eldith DC-stimulator, configuration Sham (Device)

Outcomes

Primary Outcomes

Percentage of improvement of picture naming

Time Frame: Before stimulation and immediately after stimulation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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