Methods to Enhance Transcranial Direct Stimulation (tDCS)
7 december 2010 uppdaterad av: The University of New South Wales
Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)
tDCS has been shown to be an effective treatment for depression.
However, tDCS is a relatively new clinical tool and more needs to be understood about its use.
This study hopes to further the field of knowledge by examining how tDCS should be optimally used.
Application of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this project, tDCS application will be to the motor cortex as it provides a more ready measure of excitability.
Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated.
Using a cross-over three-arm design this study aims to investigate whether daily tDCS administered in increasing intensity across sessions leads to greater and lasting effects on brain excitability than keeping the intensity at a same dose across the days and whether the excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the excitatory effects of a single session of tDCS.
This in turn will inform on how to optimize tDCS for therapeutic applications, e.g treatment of depression.
The study hypothesis is that 5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS alone.
The second hypothesis is that the gradational increases in tDCS intensity over 5 sessions will result in greater motor cortex excitability than 5 sessions of tDCS where intensity is kept constant across sessions.
Studieöversikt
Status
Avslutad
Betingelser
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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New South Wales
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Sydney, New South Wales, Australien, 2031
- Black Dog Institute, University of New South Wales
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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 till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: ARM 1 - CONTROL
Subject given tDCS every day of the week (5 sessions) at 2 mA.
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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).
Andra namn:
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).
Andra namn:
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Experimentell: 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).
Andra namn:
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).
Andra namn:
|
|
Experimentell: ARM 3 - CYCLOSERINE
D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.
Tidsram: 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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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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Samarbetspartners och utredare
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Publikationer och användbara länkar
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Användbara länkar
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 januari 2010
Primärt slutförande (Faktisk)
1 juli 2010
Avslutad studie (Faktisk)
1 juli 2010
Studieregistreringsdatum
Först inskickad
2 juni 2010
Först inskickad som uppfyllde QC-kriterierna
2 juni 2010
Första postat (Uppskatta)
3 juni 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 december 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 december 2010
Senast verifierad
1 december 2010
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HREC09344
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .