NCT05005013|CompletedPhase 2Results
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Sponsor study identifier
interventional
52
1 country
1
Study Start
September 13, 2022
Actual (reported)Primary Completion
February 14, 2024
Actual (reported)Study Completion
May 22, 2024
Actual (reported)The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 22, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2021
Actual (reported)August 13, 2021
Actual (reported)September 13, 2022
Actual (reported)February 14, 2024
Actual (reported)May 22, 2024
Actual (reported)June 24, 2025
Actual (reported)Change in Kessler Psychological Distress Scale (K10) Score
K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.
Baseline, End of Intervention (Week 4)
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Baseline, End of Intervention (Week 4)
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Baseline, End of Intervention (Week 4)
Change in Kessler Psychological Distress Scale (K10) Score
End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
End of Intervention (Week 4), Month 3
Change in Marijuana Craving Questionnaire (MCQ-17) Score
End of Intervention (Week 4), Month 3
Change in Cannabis Withdrawal Scale (CWS) Score
End of Intervention (Week 4), Month 3
tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.
The tDCS device is programmed to mimic active tDCS.
NYU Langone Health
New York, New York, 10017, United States
Leigh Charvet, PhD
NYU Langone Health
52 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2021
First Posted
August 13, 2021
Study Start
September 13, 2022
Actual (reported)Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study
Change in Marijuana Craving Questionnaire (MCQ-17) Score
MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Baseline, End of Intervention (Week 4)
Change in Cannabis Withdrawal Scale (CWS) Score
The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.
Baseline, End of Intervention (Week 4)
Change in Number of Weekly Sessions of Cannabis Use
Self-reported measure.
Baseline, End of Intervention (Week 4)
Change in Number of Monthly Sessions of Cannabis Use
Self-reported measure.
Baseline, End of Intervention (Week 4)
Participants will follow an audio track for guided mindfulness during the stimulation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 14, 2024
Actual (reported)Study Completion
May 22, 2024
Actual (reported)Last Updated
June 24, 2025
Results First Posted
June 24, 2025
Record last verified: 2025-06
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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