Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02612753
Recruitment Status : Unknown
Verified July 2016 by AZOUVI, Centre d'Investigation Clinique et Technologique 805.
Recruitment status was:  Recruiting
First Posted : November 24, 2015
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
Fondation Paul Bennetot
Fondation Garches
Information provided by (Responsible Party):
AZOUVI, Centre d'Investigation Clinique et Technologique 805

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.

Condition or disease Intervention/treatment Phase
Aphasia Procedure: improvement of language for aphasics patients Device: Sham tDCS Device: tDCs Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aphasics Patients
Patients which have difficulties to speak. Improvement of language for aphasics patients.
Procedure: improvement of language for aphasics patients
Aphasics patients receive active stimulation during SLT

Device: tDCs
Sham Comparator: Aphasics Patients control
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
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




Primary Outcome Measures :
  1. change of number of names, without error and not repeated in the speech [ Time Frame: 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 ]

    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.



Secondary Outcome Measures :
  1. verbal fluency [ Time Frame: 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. ]
    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.

  2. working memory [ Time Frame: 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. ]
    the participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated

  3. visual exploration [ Time Frame: 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. ]
    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

  4. every day life scale [ Time Frame: 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. ]
    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

  5. likert scale [ Time Frame: at the end of the 9 th week, a likert 5 grade scale was proposed. ]
    likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612753


Contacts
Layout table for location contacts
Contact: Philippe AZOUVI, MDPHD 0033147107074 philippe.azouvi@aphp.fr
Contact: Nicolas ROCHE, MD 0033147107900 roche.nicolas@rpc.aphp.fr

Locations
Layout table for location information
France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: PHILIPPE AZOUVI, MDPHD    0033147107074    philippe.azouvi@rpc.aphp.fr   
Contact: SANDRA POTTIER, CRA    0033147104469    sandra.pottier@rpc.aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Fondation Paul Bennetot
Fondation Garches
Investigators
Layout table for investigator information
Principal Investigator: Philippe AZOUVI, MDPHD Hopital RAYMOND POINCARE

Publications of Results:
Layout table for additonal information
Responsible Party: AZOUVI, MDPHD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02612753     History of Changes
Other Study ID Numbers: 2014-A01773-44
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by AZOUVI, Centre d'Investigation Clinique et Technologique 805:
Aphasia
Speaking therapy
Language therapy
transcranial Direct current stimulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Communication Disorders
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders