Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
GrayMatters Health Ltd.
Study ID
NCT06982820
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Prism Training — DEVICE
    Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.

Study Details

The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting. During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).

Key Dates

Start date
Jun 25, 2025
Status verified
Mar 2026
Primary completion
May 30, 2027
Completion
Aug 30, 2027

Study Design

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

Arms

  • Active Comparator: Active arm
    Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.
  • Sham Comparator: Sham arm
    Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.

Primary Outcome Measure

HDRS-21 [ Time Frame: Change from baseline to week 12 (post training visit) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Butler HospitalProvidenceRhode Island02906
Eric Tirrell
[email protected]
401-455-6633
Linda Carpenter, MD (PRINCIPAL_INVESTIGATOR)
Houston Center For Advanced Psychiatric TreatmentHoustonTexas77401
Sarah Hartigan
[email protected]
832-730-5196
Crystal Islas
[email protected]
(832) 436-4055 x110
Sandhya Prashad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Providence, RI

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Butler Hospital· Providence, RIHouston Center For Advanced Psychiatric Treatment· Houston, TX

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