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

May 13, 2026 updated by: North Shore Therapeutics, Inc.

Investigating a Gamified NegatIve-symptom Therapeutic Based on Evidence-based Cognitive Therapy (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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will evaluate NST-SPARK v2.0 in a 12-week, single-arm, open-label clinical trial in 30 individuals with schizophrenia spectrum disorders (SSD) who exhibit moderate to severe negative symptoms. Participants will be recruited from stable outpatient populations at Zucker Hillside Hospital (n=20) and the University of Pennsylvania (n=10). The primary objective of the study is to assess the feasibility and acceptability of NST-SPARK, along with generating preliminary evidence of efficacy in reducing experiential negative symptoms. Secondary objectives include evaluating changes in defeatist beliefs, effort expenditure, affect, global functioning, and overall symptom burden, as well as characterizing user engagement and collecting qualitative feedback to inform future product development. The investigators hypothesize that NST-SPARK will demonstrate strong feasibility and acceptability, defined by mean Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM) scores greater than 3.5, and adherence exceeding 75% of prescribed sessions. The investigators further expect to observe moderate improvements in experiential negative symptoms and reductions in defeatist beliefs. Eligible participants will be adults aged 18 and older with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychotic disorder. All participants must be clinically stable, with no recent exacerbation of positive symptoms, hospitalization, or medication changes within the prior month. Participants must exhibit moderate to severe negative symptoms, defined by a CAINS Motivation and Pleasure (MAP) subscale score greater than 17, and must have sufficient cognitive and functional capacity to consent and participate in a longitudinal study. Participants will be excluded if they present a significant safety risk (including recent suicidal or homicidal ideation), have impairments that would prevent use of a smartphone-based intervention (e.g., severe sensory or physical limitations), have an estimated IQ below 70, or demonstrate cognitive or psychiatric conditions that would limit engagement (including active mood episodes such as mania or major depression). Participants will access NST-SPARK either on their personal compatible smartphone or on a study-provided device. A trained research coordinator at each site will support onboarding, conduct assessments, and provide technical assistance. Outcome assessments will be conducted by centralized raters blinded to study conditions for key endpoints. Participants will be instructed to engage with the application at least three times per week over the 12-week treatment period, with the option for more frequent use. Based on prior experience in this population, approximately 20 participants are anticipated to complete the study. Study activities will begin with a screening phase to confirm eligibility, followed by baseline assessments prior to initiating treatment. Participants will then complete interim follow-up assessments at weeks 3, 6, and 9, and a final endpoint assessment at week 12. Recruitment will begin after finalization of the NST-SPARK v2.0 platform, with enrollment occurring over approximately 10 months at a rate of 3-4 participants per month. This will be followed by a three-month period for completion of follow-up assessments and an additional three months for data analysis, manuscript preparation, and planning of a subsequent Phase II study. Input from individuals with lived experience will be incorporated throughout the trial to contextualize findings and inform future study design. Participants will undergo a comprehensive assessment battery spanning diagnostic, symptomatic, behavioral, and functional domains. Diagnostic eligibility will be confirmed during screening using structured clinical interviews focused on mood and psychotic disorders, with additional screening to exclude individuals with significant depressive symptoms. All analyses will be conducted on available data regardless of adherence to the intervention. Given the exploratory nature of this early-stage study, adjustments for multiple comparisons will not be applied. Approximately 20 participants are anticipated to complete the study after accounting for expected attrition. This sample size provides sufficient statistical power to detect moderate treatment effects in within-subject analyses. Key indicators of success include demonstration of strong feasibility and acceptability, meaningful engagement with the intervention, and at least moderate improvement in experiential negative symptoms. In addition, successful completion of this study is expected to yield a trial-ready version of NST-SPARK capable of delivering a full 12-week therapeutic experience, incorporating both cognitive-behavioral and augmented reality components.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-65 years
  • Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or unspecified psychotic disorder
  • Clinically stable, defined as no acute positive psychotic symptom exacerbation or recent hospitalization or medication changes within the last month.
  • Moderate to severe negative symptoms: CAINS MAP subscale >17 (28).
  • Sufficient functioning and capacity to consent and participate in a longitudinal study.
  • Actively engaged in outpatient treatment.
  • Able and willing to use a smartphone and maintain internet connection during use (through wifi or data plan).

Exclusion Criteria:

  • Safety risk (e.g., suicide attempt or homicidal ideation within 12 weeks)
  • Issues that prevent subject from using the smartphone app: e.g., hearing, vision, or other relevant physical disability
  • IQ < 70 based on clinical and historical information
  • Cognitive impairment limiting engagement in study
  • Prominent mood symptoms as defined by active manic, hypomanic or depressive episode.
  • Has previously undergone cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for negative symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Experiential negative symptoms
Time Frame: This measure will be collected at baseline and at the 12-week endpoint.
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.
This measure will be collected at baseline and at the 12-week endpoint.
Acceptability
Time Frame: This measure will be collected at the 12-week endpoint.
Acceptability of NST-SPARK v.2.0 will be assessed with the Acceptablilty of Intervention Measure self-report scale (AIM). The AIM consists of 4 items, each scored on a 5-point Likert scale (1 = Completely Disagree to 5 = Completely Agree). The score is reported as the mean of the 4 items, ranging from 1 to 5. Higher scores indicate greater acceptability (better outcome).
This measure will be collected at the 12-week endpoint.
Feasibility
Time Frame: This measure will be collected at the 12-week endpoint.
Feasibility of NST-SPARK v.2.0 will be assessed with the Feasibility of Intervention Measure self-report scale (FIM). The FIM consists of 4 items, each scored on a 5-point Likert scale (1 = Completely Disagree to 5 = Completely Agree). The score is reported as the mean of the 4 items, ranging from 1 to 5. Higher scores indicate greater perceived feasibility (better outcome).
This measure will be collected at the 12-week endpoint.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Functioning
Time Frame: This measure will be collected at baseline and at the 12-week endpoint.
Global role and social functioning will be assessed with the Global Functioning (GF) scales from Cornblatt et al. Global role and social functioning will be assessed with the Global Functioning (GF) scales from Cornblatt et al. Each scale is a single-item rating scored from 1 to 10. Higher scores indicate better functioning (better outcome).
This measure will be collected at baseline and at the 12-week endpoint.
Defeatist Beliefs
Time Frame: This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Defeatist performance beliefs will be assessed with the Beck Defeatist Belief Scale (DBS) self-report. The DBS consists of 15 items, each scored on a 7-point Likert scale (1 = Disagree Totally to 7 = Agree Totally).The score is reported as the total across all 15 items, which ranges from 15 to 105. Higher scores indicate stronger defeatist beliefs (worse outcome). In addition, we will report factor scores for Overvaluing Success (6 items), Overvaluing Failure (7 items), and Overvaluing Social Evaluation (3 items). Factor scores will be reported as a mean item score for that factor from 1 to 7.
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Positive Self Regard
Time Frame: This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Positive self regard will be assessed with the Oxford Positive Self (OxPos) self-report scale. There are 24 items rated as a likert scale (0=Do not believe it, 4=believe it totally). The OxPos score will be reported as a total score, which ranges from 0 - 96, with higher score indicating better positive self regard (good outcome). In addition, we may explore the factor scores for Mastery, Strength, Enjoyment, and Character which each range from 0-28.
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Effort Expenditure
Time Frame: This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Objective effort expenditure will be measured using a computerized verison of the Progressive Ratio Test (PRT). The primary outcome is the breakpoint, defined as the maximum effort a participant is willing to exert for a given reward. There are no fixed minimum and maximum scale values in the traditional sense; breakpoint values are continuous and depend on task parameters. Higher breakpoints indicate greater motivation (better outcome).
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Loneliness
Time Frame: This measure will be collected at baseline and at the 12-week endpo
Loneliness will be assessed via self-report with the UCLA Loneliness Scale short form (UCLA-LS-3). The UCLA-LS-3 (3-item version) consists of 3 items, each scored on a 3-point scale (1 = Hardly Ever to 3 = Often). Total scores range from 3 to 9. Higher scores indicate greater loneliness (worse outcome).
This measure will be collected at baseline and at the 12-week endpo
Overall Psychosis Symptoms
Time Frame: This measure will be collected at baseline and at the 12-week endpoint.
Overall psychosis symptoms will be assessed with the COMPASS Clinician Rating Form developed for the RAISE-ETP study (COMPASS-10). The COMPASS-10 consists of 10 items. Each item is scored on a scale from 0 to 7, yielding a total score range of 0 - 60. Higher scores indicate more severe psychosis symptoms (worse outcome).
This measure will be collected at baseline and at the 12-week endpoint.
Qualitative Feedback on App Experience
Time Frame: This measure will be collected at the 12-week endpoint.
Qualitative feedback will be collected for NST-SPARK through a semi-structured interview. These results will be reported descriptively, using quotes and summaries of the participants' responses.
This measure will be collected at the 12-week endpoint.
Vocal Biomarker Composite Score
Time Frame: This measure will be collected at baseline and at the 12-week endpoint.
Vocal biomarkers composite score for negative symptoms will be extracted from recorded clinical assessments with the centralized rater. Assessments with the CAINS, GF, and COMPASS-10 will be used. The vocal biomarkers will be scored via a single composite z-score benchmarked against external datasets. The composite will be based on external data, compiling which biomarkers are associated with negative symptoms. The definitive way the score will be compiled is still pending ongoing independent studies at this time. There is no minimum or maximum score. Higher score means that the vocal features are more aligned with the expected phenotype for negative symptoms (greater severity).
This measure will be collected at baseline and at the 12-week endpoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Shore Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
Northwell Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moein Foroughi, MD, Feinstein Institute for Medical Research
  • Principal Investigator: Christian Kohler, MD, Hospital of the University of Pennsylvania, Perelman School of Medicine
  • Principal Investigator: Dan Wolf, MD, Hospital of the University of Pennsylvania, Perelman School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NST-SPARK-Phase1
  • R41MH140642-01A1 (Other Grant/Funding Number: NIMH - Status Pending)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not required for NIMH Phase 1 STTR, but we may shared fully deidentified metadata as a part of the peer-review process for resulting publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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