Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic

Not Applicable

Completed

• Conditions: Cognition; Cigarette Smoking; Schizophrenia
• Interventions: Device: tDCS

• Registration Number: NCT02128919
• Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-04-26
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2016-12-17
• Results First Submitted QC: 2017-07-25
• Status Verified: 2017-08
• Results First Posted: 2017-08-25
• Last Update Submitted: 2017-08-27
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	tDCS	tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
Sham tDCS	tDCS	tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cigarette Craving	Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Cognitive Performance	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.

Trial Locations

Locations (1)

Nathan Kline Institute for Psychiatric Research; 🇺🇸 Orangeburg, New York, United States