Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient (Taph)

Centre d'Investigation Clinique et Technologique 805

Status: Unknown

Conditions: Aphasia

Treatments: Procedure: improvement of language for aphasics patients; Device: Sham tDCS; Device: tDCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02612753

2014-A01773-44

Details and patient eligibility

About

Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate. Several studies have investigated the link between the recovery of language and neural reorganization. tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients. However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated. That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

Full description

This is a multicenter, cross-over, randomized, controlled and double blind study. 24 patients will be included between November 2015 and November 2017.

During each session of speech and language treatment, aphasics will receive a weak 2 milli amperes (electric) current delivered by a tDCs device for 20 minutes. The stimulation will be either active or placebo. Each stage of the cross over will last three weeks. Patients will be administered the usual number of SLT sessions, no particular therapy being imposed. To evaluate the long-time effects of the therapy, three follow-up measures will be proposed.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient more than 18 years
• Aphasic Following a brain injury identified by MRI.
• Present a aphasia severity score> 1 on the Boston Diagnostic Aphasia Examination (BDAE) severity scale.
• No Post stroke delay is retained but the patient should be stable from a medical point of view.
• Master Of the French language in spoken and written
• Affiliated to a social security
• Patient Who signed the informed consent

Exclusion criteria

• Other previous neurological pathologies
• epileptic crisis during the previous 2 months
• Patient denies
• Presence of a cranial flap
• intracerebral metal hardware Presence
• Patient under guardianship
• Patient unable to understand the study
• Patient subject to an exclusion period for another search.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 2 patient groups

Aphasics Patients

Experimental group

Description:

Patients which have difficulties to speak. Improvement of language for aphasics patients.

Treatment:

Device: tDCs

Procedure: improvement of language for aphasics patients

Aphasics Patients control

Sham Comparator group

Description:

Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control

Treatment:

Procedure: improvement of language for aphasics patients

Device: Sham tDCS