NCT06641297

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

October 11, 2024

Last Update Submit

February 18, 2026

Conditions

Keywords

musictrainingplasticity

Outcome Measures

Primary Outcomes (1)

  • White matter microstructure

    fractional anisotropy of white matter tracts as assessed with diffusion tensor imaging

    3 weeks

Secondary Outcomes (1)

  • Brain level of N-acetylaspartate

    3 weeks

Study Arms (2)

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

The video game \'Guitar Hero\' will be used as the platform for training for participants to acquire a new \'skill\'

Active trainingObservation training

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

RECRUITING

University of Maryland Baltimore - Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Joshua J Chiappelli, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 15, 2024

Study Start

January 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations