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

Schizophrenia Clinical Trial

— TDCSSCHIZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128919
• Other study ID #: 309320
• Status: Completed
• Phase: N/A
• First received: April 26, 2014
• Last updated: August 27, 2017
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Cognition
• Cognition Disorders
• Schizophrenia

Intervention

Device:
• tDCS
Transcranial Direct Current Stimulation

Locations

Country	Name	City	State
United States	Nathan Kline Institute for Psychiatric Research	Orangeburg	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith RC, Boules S, Mattiuz S, Youssef M, Tobe RH, Sershen H, Lajtha A, Nolan K, Amiaz R, Davis JM. Effects of transcranial direct current stimulation (tDCS) on cognition, symptoms, and smoking in schizophrenia: A randomized controlled study. Schizophr Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Psychiatric Symptoms	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.	Baseline and after 5 tDCS sessions
Primary	Change From Baseline in Cigarette Craving	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.	Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
Secondary	Change From Baseline in Cognitive Performance	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)