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Device

tDCS intervention applied by Starstim device for Depression

N/A
Waitlist Available
Research Sponsored by Neuroelectrics Corporation
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 from baseline to the 4-week follow-up
Awards & highlights

Summary

This trial will test the feasibility of using tDCS to treat people with depression at home. If it is successful, it could lead to more widespread use of this treatment.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the 4-week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the 4-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Serious Adverse Events (SAE)
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
Percentage of incomplete and missed sessions (%)
Secondary study objectives
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score
Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score
Response rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
All patients will receive active treatment which consists of stimulation (tDCS) applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents).

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Who is running the clinical trial?

Neuroelectrics CorporationLead Sponsor
7 Previous Clinical Trials
398 Total Patients Enrolled
1 Trials studying Depression
60 Patients Enrolled for Depression
~9 spots leftby Sep 2025
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