Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Pulvinar Neuro, LLC
Study ID
NCT07282678
Status
Not Yet Recruiting

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Conditions

  • Depression - Major Depressive Disorder
  • Transcranial Alternating Current Stimulation

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Closed-loop tACS — DEVICE
    Individual alpha tACS
  • Sham Comparator — DEVICE
    Sham stimulation

Study Details

The purpose of this research study is to investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder

Key Dates

First listed
Dec 15, 2025
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Closed-loop tACS
    Closed-loop individual alpha tACS daily for five consecutive days.
  • Sham Comparator: Sham Closed-loop tACS
    Sham closed-loop individual alpha tACS daily for five consecutive days.
  • Experimental: Open Label, Active Closed-loop tACS Retreatment
    An open label, second dose of Closed-loop individual alpha tACS daily for five consecutive days. Assignment to this arm occurs after participation in the closed label active or sham arms.

Primary Outcome Measure

Response rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score) at Week 3 Phase 1 Evaluation [ Time Frame: Timeframe: Baseline to Week 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Qortical Clinical PartnersDurhamNorth Carolina27707
Genesis Garcia
[email protected]
910-477-4947
David Rubinow, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Qortical Clinical Partners· Durham, NC

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