- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
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Orangeburg, New York, Förenta staterna, 10962
- Nathan Kline Institute for Psychiatric Research
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
|
Transcranial Direct Current Stimulation
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Sham Comparator: Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
|
Transcranial Direct Current Stimulation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Cigarette Craving
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Cognitive Performance
Tidsram: Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
|
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.
|
Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Psychiatric Symptoms
Tidsram: Baseline and after 5 tDCS sessions
|
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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Robert C Smith, MD, Nathsan Kline Institute for Psychiatric Research
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 309320
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