White Matter Plasticity in Schizophrenia | NCT06641297

Studies
White Matter Plasticity in Schizophrenia

NCT06641297

Sponsor

University of Maryland, Baltimore

Status

Recruiting

Last Update Posted

Feb 20, 2026Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Schizophrenia Disorders

Interventions

Music video game

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 11, 2024

First Submission Date that Met QC Criteria

Oct 11, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2026

Last Update Posted Date

Feb 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Schizophrenia spectrum disorders are associated with impairment in the microstructure of white matter, the key brain tissue responsible for fast communication between different brain regions necessary for any complex task. This white matter impairment is linked to problems with cognition in schizophrenia, especially slower processing speed. This project aims to study the potential for correcting white matter deficits in schizophrenia by examining mechanisms underlying white matter structure changes in response to training on playing a mock musical instrument.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active training	Active Comparator	Training sessions involving playing the video game 'Guitar Hero'	Behavioral: Music video game
Observation training	Placebo Comparator		Behavioral: Music video game

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music video game	Behavioral	The video game 'Guitar Hero' will be used as the platform for training for participants to acquire a new 'skill'	Active training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
White matter microstructure	fractional anisotropy of white matter tracts as assessed with diffusion tensor imaging	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Brain level of N-acetylaspartate	NAA levels in motor cortex of brain as measured with magnetic resonance spectroscopy	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis NOS
age 15-45
able to provide informed consent

Exclusion Criteria:

contraindications to MRI (metal implants, claustrophobia)
medical condition that limits use of hands (ie, arthritis)
Active or recent (within 6 months) substance use disorder other than nicotine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joshua J Chiappelli, MD	Contact	4104026827		jchiappe@som.umaryland.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maryland Psychiatric Research Center	Recruiting	Catonsville	Maryland	21228	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided