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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS + Mindfulness | Experimental |
| |
| Sham tDCS + Mindfulness | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10017 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS + Mindfulness | Transcranial Direct Current Stimulation (tDCS): 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. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. |
| FG001 | Sham tDCS + Mindfulness | Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS + Mindfulness | Transcranial Direct Current Stimulation (tDCS): 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. Mindfulness: Participants will follow an audio track for guided mindfulness during the 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 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, End of Intervention (Week 4) |
|
4 weeks
non-systematic assessment: self-reporting by participants
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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 + Mindfulness | Transcranial Direct Current Stimulation (tDCS): 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. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Lustberg | NYU Langone Health | 929-455-5090 | matthew.lustberg@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2023 | May 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2023 | Jan 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham - Transcranial Direct Current Stimulation (tDCS) | Other | The tDCS device is programmed to mimic active tDCS. |
|
| Mindfulness | Other | Participants will follow an audio track for guided mindfulness during the stimulation. |
|
| 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) |
| End of Intervention (Week 4), Month 3 |
| 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. | End of Intervention (Week 4), Month 3 |
| 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. | End of Intervention (Week 4), Month 3 |
| 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. | End of Intervention (Week 4), Month 3 |
| 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. | End of Intervention (Week 4), Month 3 |
| Change in Number of Weekly Sessions of Cannabis Use | Self-reported measure. | End of Intervention (Week 4), Month 3 |
| Change in Number of Monthly Sessions of Cannabis Use | Self-reported measure. | End of Intervention (Week 4), Month 3 |
| Ineligibility |
|
| BG001 |
| Sham tDCS + Mindfulness |
Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham tDCS + Mindfulness | Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, End of Intervention (Week 4) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, End of Intervention (Week 4) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, End of Intervention (Week 4) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, End of Intervention (Week 4) |
|
|
|
| Primary | Change in Number of Weekly Sessions of Cannabis Use | Self-reported measure. | Posted | Mean | Standard Deviation | Sessions per week | Baseline, End of Intervention (Week 4) |
|
|
|
| Primary | Change in Number of Monthly Sessions of Cannabis Use | Self-reported measure. | Posted | Mean | Standard Deviation | Sessions per month | Baseline, End of Intervention (Week 4) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | Change in Number of Weekly Sessions of Cannabis Use | Self-reported measure. | Posted | Mean | Standard Deviation | Sessions per week | End of Intervention (Week 4), Month 3 |
|
|
|
| Secondary | Change in Number of Monthly Sessions of Cannabis Use | Self-reported measure. | Posted | Mean | Standard Deviation | Sessions per month | End of Intervention (Week 4), Month 3 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Sham tDCS + Mindfulness | Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation. | 0 | 13 | 0 | 13 | 1 | 13 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |