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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: Clinical Trial NA study, sponsored by North Shore Therapeutics.
NCT07593456 is a NA study that has not yet begun recruiting, run by North Shore Therapeutics. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Experiential negative symptoms include avolition, asociality and anhedonia and will be assessed with the Motivation and Pleasure (MAP) subscale of the Clinical Assessment Interview for Negative Symptoms (CAINS). The MAP scale as an aggregate measure adds together the 9 individual items each ranging from 0 to 4; as an aggregate measure, the CAINS-MAP score ranges from 0 to 36 with 36 representing greater symptom severity.
Interventions
- DEVICE NST-SPARK
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2027-03-01 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
What is known before NCT07593456 opens enrollment
NCT07593456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which NST-SPARK is the first listed.
NCT07593456 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07593456's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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