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

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ClinicalTrials.gov Identifier: NCT02128919
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 25, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Robert C. Smith MD PhD, 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Cognition Cigarette Smoking Device: tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic
Study Start Date : April 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
Device: tDCS
Transcranial Direct Current Stimulation

Sham Comparator: Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
Device: tDCS
Transcranial Direct Current Stimulation




Primary Outcome Measures :
  1. Change From Baseline in Cigarette Craving [ Time Frame: 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 :
  1. Change From Baseline in Cognitive Performance [ Time Frame: 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.


Other Outcome Measures:
  1. Change From Baseline in Psychiatric Symptoms [ Time Frame: 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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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128919


Locations
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United States, New York
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Investigators
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Principal Investigator: Robert C Smith, MD Nathsan Kline Institute for Psychiatric Research

Publications of Results:
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Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT02128919     History of Changes
Other Study ID Numbers: 309320
First Posted: May 1, 2014    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:
Schizophrenia
Cigarette smoking
Cognition
Craving
MATRICS

Additional relevant MeSH terms:
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Schizophrenia
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders