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NCT07593456 · ClinicalTrials.gov registry record · NA
NST-SPARK Open-Label Phase 1 STTR (IGNITE)
A NA study, sponsored by North Shore Therapeutics.
- Not yet
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT07593456 is a NA study that has not yet begun recruiting, run by North Shore Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT07593456, a NA study, has not yet begun recruiting, sponsored by North Shore Therapeutics.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Schizophrenia Spectrum disorders (SSD) are among the most devastating psychiatric disorders. Prominent negative symptoms such as low motivation, anhedonia, asociality, and emotional flattening are experienced by up to 60% of individuals with SSD and are often considered to be the greatest contributors to functional disability. Currently, there are no FDA-approved or cleared medications or therapeutics targeting negative symptoms of schizophrenia. In this phase I proposal, North Shore Therapeutics (NST) is collaborating with the Feinstein Institutes of Medical Research (FIMR; Northwell Health) and the University of Pennsylvania (Penn) to develop a novel augmented reality (AR) therapeutic (NST-SPARK) targeting negative symptoms in individuals with SSD. NST-SPARK is a smartphone application that delivers Recovery-oriented Cognitive Therapy (CT-R) via gamified AR experiences to provide experiential learning that dismantles maladaptive beliefs. Preliminary findings suggest that this approach is feasible, acceptable, and may reduce defeatist beliefs associated with negative symptoms. NST-SPARK v.2.0 is being developed in partnership with a lived experience advisory panel. NST-SPARK v2.0 will deliver a 12-week course of treatment and will be developed over 10 development sprints spanning 9 months. In the second phase, the investigators will introduce NST-SPARK v2.0 to individuals with SSD (n=30) and moderate to severe negative symptoms for 12 weeks in a single-arm open-label study. The primary outcome is the efficacy of NST-SPARK v.2.0 in reducing experiential negative symptoms. Secondary outcomes include efficacy in reducing defeatist beliefs; efficacy in improving functioning; user statistics quantifying adherence to the prescribed sessions; qualitative, semi-structured feedback to guide future product development. This study will set the stage for FDA-informed phase II trials.
Interventions
- DEVICE NST-SPARK
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2027-03-01 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07593456
The ClinicalTrials.gov registry entry for NCT07593456 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Shore Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NST-SPARK is the first listed.
NCT07593456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07593456 about?
NCT07593456 is a clinical study titled "NST-SPARK Open-Label Phase 1 STTR (IGNITE)". Schizophrenia Spectrum disorders (SSD) are among the most devastating psychiatric disorders. Prominent negative symptoms such as low motivation, anhedonia, asociality, and emotional flattening are experienced by up to 60% of individuals with SSD and are often considered to be the greatest contributo...
What is the current status of trial NCT07593456?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2027-03-01. Estimated completion is 2028-08-31.
What interventions are being tested in trial NCT07593456?
The interventions under investigation include: NST-SPARK (DEVICE).
Who is sponsoring clinical trial NCT07593456?
This trial is sponsored by North Shore Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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