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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days |
|
| Sham tDCS | Sham Comparator | tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Transcranial Direct Current Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Smith, MD | Nathsan Kline Institute for Psychiatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26190299 | Result | 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 Res. 2015 Oct;168(1-2):260-6. doi: 10.1016/j.schres.2015.06.011. Epub 2015 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation |
| FG001 | Sham tDCS | tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation |
| BG001 | Sham tDCS | tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Findings are based on31 subjects (15 active tDCS and 16 sham tDCS) who completed this QSU-Brief questionnaire in at baseline and after 5 tDCS sessions.. Complete sample who entered study and were randomized were 33 subjects 24 male and 9 female, but all subjects did not complete QSU brief rating scale.. | Posted | Least Squares Mean | Standard Error | Units on QSU-Brief Scale | Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine) |
|
fuyll course of study over 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert C Smith MD | Nathan Kline institute for Psycghatric Research | 845-398-6531 | rsmiith@nki.rfmh.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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) |
| Baseline and after 5 tDCS sessions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Active tDCS | tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation |
| OG001 | Sham tDCS | tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation |
|
|
| 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. | Posted | Least Squares Mean | Standard Deviation | MATRICS domain difference scores | Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline) |
|
|
|
| Other Pre-specified | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Baseline and after 5 tDCS sessions |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Sham tDCS | tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation | 0 | 16 | 0 | 16 |
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| D001519 | Behavior |
| D064424 | Tobacco Use |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| MATRICS Attention/Vigilance Diff Score |
|
| PANSS Negative diff score |
|