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

Aphasia Clinical Trial

— Taph  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02612753
• Other study ID #: 2014-A01773-44
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2015
• Last updated: July 25, 2016
• Start date: November 2015
• Est. completion date: October 2018

Study information

• Verified date: July 2016
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: Philippe AZOUVI, MDPHD
• Phone: 0033147107074
• Email: philippe.azouvi[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Communication Disorders

Intervention

Procedure:
• improvement of language for aphasics patients
Aphasics patients receive active stimulation during SLT

Device:
• Sham tDCS
Aphasics patients control receive sham stimulation during SLT
• tDCs

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (3)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Fondation Garches, Fondation Paul Bennetot

Country where clinical trial is conducted

France, 

References & Publications (5)

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3. Review. — View Citation

Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD000425. — View Citation

Klippi A, Sellman J, Heikkinen P, Laine M. Current clinical practices in Aphasia Therapy in Finland: challenges in moving towards national best practice. Folia Phoniatr Logop. 2012;64(4):169-78. doi: 10.1159/000341106. Epub 2012 Oct 25. — View Citation

Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9. — View Citation

Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of number of names, without error and not repeated in the speech	The participant must answer a simple question "explain me your job or your study". Their production will be recorded and analyzed.; For evaluate the stability of participant performances before the stimulation period three based line will be propose. The third base line corresponds to the start of the first stimulation period. After the three week of tdcs coupled with the SLT a new assessment will be realized. One week later begin the new stage of cross over. An assessment will be administered just before and just after the second stimulation period. Then, three follow-up assessments (one all two weeks) will be proposed during one and half month.	Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th	No
Secondary	verbal fluency	the participant has two minutes to find the most animal names words beginning by letter p. Investigator collect the number of correct words and calculate the standard deviation according to published norms.	Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.	No
Secondary	working memory	the participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated	baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.	No
Secondary	visual exploration	a paper with a lot of drawing is presented to the participant. The participant must delete all the bells as fast as possible. Investigator collect the number of bell omissions	baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.	No
Secondary	every day life scale	a questionnaire is proposed to the participant in order to better understanding how is the communication with their close or with unknown person in a conversation or phone	Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.	No
Secondary	likert scale	likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist.	at the end of the 9 th week, a likert 5 grade scale was proposed.	No