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

NCT02612753 | Unknown

• 1 other identifier: 2014-A01773-44
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphasia

Keywords

Aphasia; Speaking therapy; Language therapy; transcranial Direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• verbal fluency

  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.

• working memory

  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.

• visual exploration

  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.

• every day life scale

  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.

• likert scale

  at the end of the 9 th week, a likert 5 grade scale was proposed.

Study Arms (2)

Aphasics Patients

EXPERIMENTAL

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

Procedure: improvement of language for aphasics patients; Device: tDCs

Aphasics Patients control

SHAM COMPARATOR

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

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

Interventions

improvement of language for aphasics patients PROCEDURE

Aphasics patients receive active stimulation during SLT

Aphasics Patients; Aphasics Patients control

Sham tDCS DEVICE

Aphasics patients control receive sham stimulation during SLT

Aphasics Patients control

tDCs DEVICE

Aphasics Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Fondation Paul Bennetot: collaborator
• Fondation Garches: collaborator

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

RECRUITING

Related Publications (5)

• Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. doi: 10.1002/14651858.CD000425.

  PMID: 10796360 RESULT

• 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(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 RESULT

• 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.

  PMID: 25929694 RESULT

• Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87. doi: 10.1044/jslhr.4101.172.

  PMID: 9493743 RESULT

• 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.

  PMID: 23108446 RESULT

MeSH Terms

Conditions

Aphasia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Philippe AZOUVI, MDPHD

  Hopital RAYMOND POINCARE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe AZOUVI, MDPHD

CONTACT

0033147107074; philippe.azouvi@aphp.fr

Nicolas ROCHE, MD

CONTACT

0033147107900; roche.nicolas@rpc.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDPHD

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: October 1, 2018
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

FR (1)