Clinical Trials Directory

Trials / Unknown

UnknownNCT02612753

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Centre d'Investigation Clinique et Technologique 805 · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREimprovement of language for aphasics patientsAphasics patients receive active stimulation during SLT
DEVICESham tDCSAphasics patients control receive sham stimulation during SLT
DEVICEtDCs

Timeline

Start date
2015-11-01
Primary completion
2017-11-01
Completion
2018-10-01
First posted
2015-11-24
Last updated
2016-07-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02612753. Inclusion in this directory is not an endorsement.