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- Klinische proef NCT02128919
Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic (TDCSSCHIZ)
This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale.
This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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Orangeburg, New York, Verenigde Staten, 10962
- Nathan Kline Institute for Psychiatric Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Diagnosis of schizophrenia spectrum disorder History of cigarette smoking
Exclusion Criteria:
- Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
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Transcranial Direct Current Stimulation
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Sham-vergelijker: Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
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Transcranial Direct Current Stimulation
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change From Baseline in Cigarette Craving
Tijdsspanne: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
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The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings.
Scores ranged from a minimum of 1 ("Strongly Disagree") to a maximum of 7 ("Strongly Agree") and were determined by self-reported responses to 10 statements about having cravings for smoking.
Scores closer to 1 after treatment would indicate a better outcome.
Responses to each of the 10 items in the scale were summed for one total score.
With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70.
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Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change From Baseline in Cognitive Performance
Tijdsspanne: Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
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The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance.
Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests.
We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data.
The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile).
The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile).
Higher scores after baseline represent better outcomes.
Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
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Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change From Baseline in Psychiatric Symptoms
Tijdsspanne: Baseline and after 5 tDCS sessions
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The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms.
Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96).
All three subscales were summed for the PANSS total score (total scale range: 30-180).
Scores closer to 30 after baseline represented better outcomes.
Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
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Baseline and after 5 tDCS sessions
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert C Smith, MD, Nathsan Kline Institute for Psychiatric Research
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 309320
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