NST-SPARK for Schizophrenia

(IGNITE Trial)

Not yet recruiting at 1 trial location

Overseen By William Cronin, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: North Shore Therapeutics, Inc.

Disqualifiers: Suicide risk, Physical disability, Low IQ, Cognitive impairment, Mood symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called NST-SPARK, which uses augmented reality to help people with schizophrenia manage challenging symptoms like low motivation and emotional flatness. The app aims to change negative beliefs through engaging, game-like experiences. Researchers seek to determine if this approach can improve daily functioning and reduce these difficult symptoms. The trial seeks participants diagnosed with schizophrenia or similar disorders, who experience moderate to severe negative symptoms, and are comfortable using a smartphone regularly. As an unphased trial, this study offers a unique opportunity to explore innovative technology that could enhance quality of life.

What prior data suggests that the NST-SPARK device is safe for individuals with schizophrenia?

Research has shown that the NST-SPARK app, which uses augmented reality (AR) for therapy, is generally easy for users to handle. In earlier studies with previous versions of the app, participants did not report any serious side effects. The app aims to help people with schizophrenia by addressing issues like low motivation and lack of emotional expression.

Initial results from trials with 20 participants indicated that using the app was practical and acceptable. Participants used the app regularly, and no major negative effects were reported. This suggests that the treatment is safe for users.

While the app is still undergoing testing, these early results are promising for its safety and ease of use. It's important to remember that the app remains in the early stages of development, so researchers continue to monitor and ensure its safety for future users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for schizophrenia, like antipsychotic medications, focus on balancing chemicals in the brain to reduce symptoms. But NST-SPARK is different because it is a smartphone-based digital therapeutic, offering a non-drug approach. This app delivers therapy through interactive modules over 12 weeks, providing an accessible and engaging way for patients to manage their condition. Researchers are excited because it offers a new method of treatment that could complement existing therapies, potentially enhancing outcomes without the side effects associated with medication.

What evidence suggests that NST-SPARK is effective for negative symptoms of schizophrenia?

Research has shown that NST-SPARK, a smartphone app using augmented reality and cognitive therapy, may help reduce negative symptoms of schizophrenia. In a study with 20 participants, the app led to moderate improvements in symptoms like low motivation and lack of emotional expression. Users also reported feeling less defeated, which can exacerbate these symptoms. Early results suggest that this digital treatment is practical and acceptable for people with schizophrenia-related disorders. Although still in the early stages, the app could offer a new way to address symptoms that current medications do not specifically target. Participants in this trial will use the NST-SPARK v.2.0 version, which includes 12 weeklong modules accessed via a smartphone app. ^{1 2 3 4 6}

Who Is on the Research Team?

Moein Foroughi, MD

Principal Investigator

Feinstein Institute for Medical Research

Christian Kohler, MD

Principal Investigator

Hospital of the University of Pennsylvania, Perelman School of Medicine

Dan Wolf, MD

Principal Investigator

Hospital of the University of Pennsylvania, Perelman School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with schizophrenia or related disorders who have moderate to severe negative symptoms like low motivation, lack of pleasure, social withdrawal, or emotional flatness. Participants should be able to use a smartphone and take part in therapy sessions.

Inclusion Criteria

I am between 18 and 65 years old.

I have been mentally stable with no recent hospitalizations or medication changes.

I have been diagnosed with a schizophrenia spectrum or psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments are conducted prior to initiating treatment

1 week

1 visit (in-person)

Treatment

Participants engage with the NST-SPARK v2.0 application at least three times per week over 12 weeks

12 weeks

Weekly virtual check-ins

Follow-up

Participants complete interim follow-up assessments at weeks 3, 6, and 9, and a final endpoint assessment at week 12

3 months

4 visits (in-person)

Data Analysis and Planning

Data analysis, manuscript preparation, and planning of a subsequent Phase II study

3 months

What Are the Treatments Tested in This Trial?

Interventions

• NST-SPARK

Trial Overview

The study is testing NST-SPARK v2.0, a new smartphone app that uses augmented reality games and cognitive therapy techniques over 12 weeks to help reduce negative symptoms in people with schizophrenia spectrum disorders.

How Is the Trial Designed?

Group I: NST-SPARK v.2.0 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

North Shore Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06653829

NST-SPARK: Preliminary Study of an Augmented Reality ...

This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12775644/

Preliminary Findings From an Augmented Reality (AR) App ...

NST‐SPARK is a novel digital therapeutic targeting negative symptoms in schizophrenia spectrum disorders (SSD). It is a smartphone application ...

3.

medrxiv.org

medrxiv.org/content/10.1101/2024.10.28.24315453v1

Preliminary Findings from an Augmented Reality (AR) App ...

In this study, we assessed a prototype (NST-SPARK v.1.5) in 20 participants with SSD and clinically significant negative symptoms. NST-SPARK v.

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/eip.70119

Preliminary Findings From an Augmented Reality (AR) App ...

NST-SPARK is a novel digital therapeutic targeting negative symptoms. It is designed as a smartphone application that delivers recovery-oriented ...

5.

ctv.veeva.com

ctv.veeva.com/study/nst-spark-preliminary-study-of-an-augmented-reality-ar-app-delivering-recovery-oriented-cognitive

NST-SPARK: Preliminary Study of an Augmented Reality (AR ...

This study evaluates the feasibility and acceptability of a prototype for NST-SPARK (version 1.5). This is an augmented reality (AR) mobile ...

6.

clicktherapeutics.com

clicktherapeutics.com/news/boehringer-and-click-therapeutics-investigational-prescription-digital-therapeutic-ct-155-meets-primary-endpoint-in-convoke-study-for-negative-symptoms-in-schizophrenia

Stay up to date with news and updates

Boehringer and Click Therapeutics' investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in ...