- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02612753
Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient (Taph)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Garches, Frankrijk, 92380
- Werving
- Hôpital Raymond Poincaré
-
Contact:
- PHILIPPE AZOUVI, MDPHD
- Telefoonnummer: 0033147107074
- E-mail: philippe.azouvi@rpc.aphp.fr
-
Contact:
- SANDRA POTTIER, CRA
- Telefoonnummer: 0033147104469
- E-mail: sandra.pottier@rpc.aphp.fr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Aphasics Patients
Patients which have difficulties to speak.
Improvement of language for aphasics patients.
|
Aphasics patients receive active stimulation during SLT
|
Sham-vergelijker: Aphasics Patients control
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
|
Aphasics patients receive active stimulation during SLT
Aphasics patients control receive sham stimulation during SLT
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
change of number of names, without error and not repeated in the speech
Tijdsspanne: 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. |
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
verbal fluency
Tijdsspanne: 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.
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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.
|
at the end of the 9 th week, a likert 5 grade scale was proposed.
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Philippe AZOUVI, MDPHD, Hôpital Raymond Poincaré
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014-A01773-44
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .