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Device
transcranial direct current stimulator (tDCS) for Cocaine Dependence
Phase 2
Waitlist Available
Led By Abhishek Datta, PhD
Research Sponsored by Soterix Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (1 month, 3 month)
Summary
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.
Eligible Conditions
- Cocaine Use Disorder
- Cocaine Dependence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (1 month, 3 month)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (1 month, 3 month)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
Secondary study objectives
Change in Anxiety symptoms from Baseline (HAM-A score)
Change in Depression symptoms from Baseline (Ham-D score)
Change in Quality of Life from Baseline (WHOQOL-BREF score)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS with Cognitive Reappraisal (CR)Experimental Treatment2 Interventions
Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)
Group II: Active tDCSExperimental Treatment1 Intervention
Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)
Group III: Sham tDCSPlacebo Group1 Intervention
Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
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Who is running the clinical trial?
Soterix MedicalLead Sponsor
10 Previous Clinical Trials
315 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
895 Previous Clinical Trials
537,369 Total Patients Enrolled
Abhishek Datta, PhDPrincipal InvestigatorSoterix Medical
2 Previous Clinical Trials
75 Total Patients Enrolled
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