- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01135953
Methods to Enhance Transcranial Direct Stimulation (tDCS)
Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New South Wales
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Sydney, New South Wales, Australia, 2031
- Black Dog Institute, University of New South Wales
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male
- Right handed (> 18/20 on the Edinburgh Handedness)
- Aged 18-40
Exclusion Criteria:
- Mental illness
- General medical illness
- Neurological illness, epilepsy
- Alcohol use above National Health and Medical Research Council (NHMRC) guidelines
- Smokers
- Excessive caffeine intake
- Illicit drug use
- Herbal medication use
- Electronic implant, e.g, cochlear implant, pacemaker
- Musculoskeletal problem in the arm
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ARM 1 - CONTROL
Subject given tDCS every day of the week (5 sessions) at 2 mA.
|
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Andre navn:
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes.
Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).
Andre navn:
|
|
Eksperimentell: Arm 2 - INCREASING
Subjects given increasing intensity during tDCS across the week (Monday 1mA, Tuesday 1.5mA, Wednesday 1.5 mA, Thursday 2 mA, Friday 2mA).
|
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Andre navn:
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes.
Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band.
The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).
Andre navn:
|
|
Eksperimentell: ARM 3 - CYCLOSERINE
D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.
|
Transcranial Direct Stimulation applied to the motor cortex every day of the week (5 sessions) at 2mA, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash). D-cycloserine, administered orally (capsules), 100 mg, twice a week (Monday and Thursday), prior to the tDCS session.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.
Tidsramme: Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.
|
Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HREC09344
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