Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101398
• Other study ID #: C12-09
• Secondary ID: 2013-A00989-36
• Status: Completed
• Phase: N/A
• Start date: October 2, 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• dementia

• 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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• eldith DC-stimulator, configuration F7A
tDCS will be delivered during a 20 minutes speech-language therapy session
• eldith DC-stimulator, configuration F7C
tDCS will be delivered during a 20 minutes speech-language therapy session
• eldith DC-stimulator, configuration T5A
tDCS will be delivered during a 20 minutes speech-language therapy session
• eldith DC-stimulator, configuration T5C
tDCS will be delivered during a 20 minutes speech-language therapy session
• eldith DC-stimulator, configuration Sham
Sham tDCS will be delivered during a 20 minutes speech-language therapy session

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of improvement of picture naming		Before stimulation and immediately after stimulation