Multiple Sclerosis Clinical Trial

A Teleheath tDCS Approach to Decrease Cannabis Use

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Ages 21-65 (inclusive)
Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
K10 score 10-35, inclusive (mild to high moderate distress)
Definite MS diagnosis, relapsing remitting (RRMS) subtype
PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures)
All medications stable for ≥ 1 month prior to enrollment and throughout the trial
Ability to understand the informed consent process and provide consent to participate in the study
Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
Ability to use mobile devices
Fluent in English language (due to outcomes validated in English versions only)
WRAT-4 score ≥ 85

Exclusion Criteria:

MS clinical relapse or use of high dose of steroids in the past month
Patients under medical marijuana use prescribed by a clinician
Alcohol, tobacco, or substance use disorder other than cannabis
Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder
Current suicidal ideation or deemed to be of potential risk of self-injury
History of traumatic brain injury
Seizure disorder or recent (<5 years) seizure history
Metal implants in the head or neck
Enrolled in group or individual therapy for substance use disorder concurrent to intervention
Any skin disorder or skin sensitive area near stimulation locations
Pregnant or breastfeeding

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

52

Study ID:

NCT05005013

Recruitment Status:

Active, not recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10017, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

52

Study ID:

NCT05005013

Recruitment Status:

Active, not recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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