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

Primary Purpose

Aphasia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
improvement of language for aphasics patients
Sham tDCS
tDCs
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Speaking therapy, Language therapy, transcranial Direct current stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hopital Raymond PoincareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Aphasics Patients

Aphasics Patients control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
working memory
the participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated
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
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
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.

Full Information

First Posted
October 29, 2015
Last Updated
July 25, 2016
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Paul Bennetot, Fondation Garches
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1. Study Identification

Unique Protocol Identification Number
NCT02612753
Brief Title
Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient
Acronym
Taph
Official Title
Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Paul Bennetot, Fondation Garches

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia, Speaking therapy, Language therapy, transcranial Direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aphasics Patients
Arm Type
Experimental
Arm Description
Patients which have difficulties to speak. Improvement of language for aphasics patients.
Arm Title
Aphasics Patients control
Arm Type
Sham Comparator
Arm Description
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
Intervention Type
Procedure
Intervention Name(s)
improvement of language for aphasics patients
Intervention Description
Aphasics patients receive active stimulation during SLT
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Aphasics patients control receive sham stimulation during SLT
Intervention Type
Device
Intervention Name(s)
tDCs
Primary Outcome Measure Information:
Title
change of number of names, without error and not repeated in the speech
Description
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.
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
Secondary Outcome Measure Information:
Title
verbal fluency
Description
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.
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.
Title
working memory
Description
the participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated
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.
Title
visual exploration
Description
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
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.
Title
every day life scale
Description
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
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.
Title
likert scale
Description
likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist.
Time Frame
at the end of the 9 th week, a likert 5 grade scale was proposed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe AZOUVI, MDPHD
Phone
0033147107074
Email
philippe.azouvi@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas ROCHE, MD
Phone
0033147107900
Email
roche.nicolas@rpc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe AZOUVI, MDPHD
Organizational Affiliation
Hopital RAYMOND POINCARE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PHILIPPE AZOUVI, MDPHD
Phone
0033147107074
Email
philippe.azouvi@rpc.aphp.fr
First Name & Middle Initial & Last Name & Degree
SANDRA POTTIER, CRA
Phone
0033147104469
Email
sandra.pottier@rpc.aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
10796360
Citation
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.
Results Reference
result
PubMed Identifier
10990547
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(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Results Reference
result
PubMed Identifier
25929694
Citation
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.
Results Reference
result
PubMed Identifier
9493743
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. doi: 10.1044/jslhr.4101.172.
Results Reference
result
PubMed Identifier
23108446
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.
Results Reference
result

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

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