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

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.

Conditions

• Schizophrenia / Schizoaffective Disorder

Interventions

DEVICE

NST-SPARK

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.

Sponsors & Collaborators

• Northwell Health

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• North Shore Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Moein Foroughi, MD · Feinstein Institute for Medical Research

• Christian Kohler, MD · Hospital of the University of Pennsylvania, Perelman School of Medicine

• Dan Wolf, MD · Hospital of the University of Pennsylvania, Perelman School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-03-01

Primary Completion

2028-02-28

Completion

2028-08-31

FDA Device

Yes

Countries

• United States

Study Locations