- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01845129
Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia (StimRAph)
30. april 2013 opdateret af: Marcus Meinzer, Charite University, Berlin, Germany
The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.
Studieoversigt
Detaljeret beskrivelse
Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design.
tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation.
Order of stimulation will be counterbalanced between subjects
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
16
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Berlin, Tyskland, 10117
- Rekruttering
- Charite, University Medicine, Dept. of Neurology
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Ledende efterforsker:
- Marcus Meinzer, PhD
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Ledende efterforsker:
- Agnes Flöel, MD
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Kontakt:
- Robert Darkow, MSc
- Telefonnummer: 395 +49 30 450 560
- E-mail: robert.darkow@charite.de
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- right handedness
- German native speaker
- cerebrovascular stroke in left hemisphere (>6 months)
- mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
- residual anomia in naming test (>75 correct responses)
Exclusion Criteria:
- other current or previous neurological or psychiatric diseases
- alcohol or drug abuse
- MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: anodal tDCS
atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex
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atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI).
The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
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Sham-komparator: sham tDCS
sham tDCS will be administered to the left primary hand motor cortex
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atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI).
The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response latency during picture naming task (max. 80)
Tidsramme: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
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Subjects are assessed in a cross-over design.
The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation.
Order of stimulation will be counterbalanced across the group.
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Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in neural activity measured by functional magnetic resonance imaging
Tidsramme: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
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Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Marcus Meinzer, PhD, Charite, University Medicine, Neurology
- Ledende efterforsker: Agnes Flöel, MD, Charite, University Medicine, Neurology
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2013
Primær færdiggørelse (Forventet)
1. april 2014
Studieafslutning (Forventet)
1. april 2014
Datoer for studieregistrering
Først indsendt
30. april 2013
Først indsendt, der opfyldte QC-kriterier
30. april 2013
Først opslået (Skøn)
3. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RAPH_01EO0801
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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