NST-SPARK Open-Label Phase 1 STTR (IGNITE)

Conditions

• Schizophrenia / Schizoaffective Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• NST-SPARK — DEVICE
  NST-SPARK v2.0 is a smartphone-based digital therapeutic that delivers recovery-oriented cognitive therapy (CT-R) through gamified augmented reality (AR) experiences to treat negative symptoms of schizophrenia spectrum disorders. Over a 12-week course, participants complete interactive sessions on their smartphone in which the app guides them to (1) identify targeted defeatist beliefs, (2) engage in brief AR activities featuring encouraging prompts and game-like challenges such as sorting objects, (3) reflect on the experience through guided cognitive restructuring, and (4) generalize insights to real-life goal-directed activities. Gamification elements including points, rewards, and progress tracking are integrated throughout to enhance engagement and reinforce effort. NST-SPARK is added to treatment as usual with no changes to participants' existing pharmacotherapy or clinical visits.

Study Details

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.

Key Dates

Start date

Mar 1, 2027

Status verified

May 2026

Primary completion

Feb 28, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: NST-SPARK v.2.0
  NST-SPARK v2.0 is a smartphone-based, software-as-a-medical-device digital therapeutic. It comprises 12 weeklong modules, and participants use the app on a personal or study-provided smartphone at least three times weekly over 12 weeks.

Primary Outcome Measure

Experiential negative symptoms [ Time Frame: This measure will be collected at baseline and at the 12-week endpoint. ]

Central Contacts

• William Cronin, MBA
  214-693-8614
  [email protected]
• Moein Foroughi, MD
  507-271-7146
  [email protected]

Locations (2)

Find similar trials in Glen Oaks, NY