Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic (NCT NCT02128919)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)

Results posted on

2017-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Active tDCS tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation	Sham tDCS tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation
Overall Study STARTED	17	16
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS n=17 Participants tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation	Sham tDCS n=16 Participants tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation	Total n=33 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 11.1 • n=5 Participants	44.9 years STANDARD_DEVIATION 9.2 • n=7 Participants	45.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized race/ethnicity · white	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized race/ethnicity · black-African american	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized race/ethnicity · hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized race/ethnicity · other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)

Population: 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..

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.

Outcome measures

Outcome measures
Measure	Active tDCS n=15 Participants tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation	Sham tDCS n=16 Participants tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation
Change From Baseline in Cigarette Craving	14.40 Units on QSU-Brief Scale Standard Error 3.57	11.00 Units on QSU-Brief Scale Standard Error 3.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active tDCS n=14 Participants tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation	Sham tDCS n=16 Participants tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation
Change From Baseline in Cognitive Performance MATRICS Composite Diff Score	3.47 MATRICS domain difference scores Standard Deviation 4.09	-0.85 MATRICS domain difference scores Standard Deviation 4.08
Change From Baseline in Cognitive Performance MATRICS Working Memory Diff Score	4.04 MATRICS domain difference scores Standard Deviation 5.70	-3.29 MATRICS domain difference scores Standard Deviation 5.68
Change From Baseline in Cognitive Performance MATRICS Attention/Vigilance Diff Score	4.25 MATRICS domain difference scores Standard Deviation 7.17	-1.91 MATRICS domain difference scores Standard Deviation 7.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active tDCS n=15 Participants tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days tDCS: Transcranial Direct Current Stimulation	Sham tDCS n=15 Participants tDCS 2 ma for 40 second s with anode at DLPFC for 5 days tDCS: Transcranial Direct Current Stimulation
Change From Baseline in Psychiatric Symptoms PANSS postive diff score	-1.70 Units on a scale Standard Deviation 3.10	-1.63 Units on a scale Standard Deviation 3.10
Change From Baseline in Psychiatric Symptoms PANSS total diff score	-1.51 Units on a scale Standard Deviation 8.01	-2.37 Units on a scale Standard Deviation 8.01
Change From Baseline in Psychiatric Symptoms PANSS Negative diff score	1.06 Units on a scale Standard Deviation 4.38	0.68 Units on a scale Standard Deviation 4.38

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert C Smith MD

Nathan Kline institute for Psycghatric Research

Phone: 845-398-6531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place