Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient (Taph)
25 juli 2016 uppdaterad av: AZOUVI, Centre d'Investigation Clinique et Technologique 805
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Garches, Frankrike, 92380
- Rekrytering
- Hôpital Raymond Poincaré
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Kontakt:
- PHILIPPE AZOUVI, MDPHD
- Telefonnummer: 0033147107074
- E-post: philippe.azouvi@rpc.aphp.fr
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Kontakt:
- SANDRA POTTIER, CRA
- Telefonnummer: 0033147104469
- E-post: sandra.pottier@rpc.aphp.fr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Aphasics Patients
Patients which have difficulties to speak.
Improvement of language for aphasics patients.
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Aphasics patients receive active stimulation during SLT
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Sham Comparator: Aphasics Patients control
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
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Aphasics patients receive active stimulation during SLT
Aphasics patients control receive sham stimulation during SLT
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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change of number of names, without error and not repeated in the speech
Tidsram: 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
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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verbal fluency
Tidsram: 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.
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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.
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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.
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working memory
Tidsram: 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.
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the participant repeats the numbers in the same order or inverted order.
Investigator collect the highest group of number repeated
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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.
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visual exploration
Tidsram: 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.
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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
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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.
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every day life scale
Tidsram: 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.
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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
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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.
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likert scale
Tidsram: at the end of the 9 th week, a likert 5 grade scale was proposed.
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likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist.
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at the end of the 9 th week, a likert 5 grade scale was proposed.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Philippe AZOUVI, MDPHD, Hôpital Raymond Poincaré
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2015
Primärt slutförande (Förväntat)
1 november 2017
Avslutad studie (Förväntat)
1 oktober 2018
Studieregistreringsdatum
Först inskickad
29 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
20 november 2015
Första postat (Uppskatta)
24 november 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014-A01773-44
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