Schizophrenia DisordersNCT06641297
White Matter Plasticity in Schizophrenia
A study testing Music video game in people with Schizophrenia Disorders, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- Music video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis NOS
- age 15-45
- able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
Joshua Chiappelli, MD, 410-402-6827, jchiappe@som.umaryland.edu
- Not yet recruiting
University of Maryland Baltimore - Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
Joshua J Chiappelli, MD, 410-402-6827, jchiappe@som.umaryland.edu
About this study
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.
- Conditions
- Schizophrenia Disorders
- Being tested
- Music video game
- Keywords
- music, training, plasticity
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music video gameBehavioural
The video game \'Guitar Hero\' will be used as the platform for training for participants to acquire a new \'skill\'
| Study group | Role | What they receive |
|---|---|---|
| Active training | Active comparator | Training sessions involving playing the video game 'Guitar Hero' Receives: Behavioral: Music video game |
| Observation training | Placebo comparator | Not described Receives: Behavioral: Music video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter microstructure
fractional anisotropy of white matter tracts as assessed with diffusion tensor imaging
Measured: 3 weeks
Secondary outcomes (1)
Brain level of N-acetylaspartate
NAA levels in motor cortex of brain as measured with magnetic resonance spectroscopy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641297
- Sponsor's protocol ID
- HP-00081020
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Plasticity in Schizophrenia
- ClinicalTrials.gov ID
- NCT06641297
- Acronym / sponsor ID
- HP-00081020
- Conditions
- Schizophrenia Disorders
- Keywords
- music, training, plasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active training | Active comparator | Behavioral: Music video gameTraining sessions involving playing the video game 'Guitar Hero' |
| Observation training | Placebo comparator | Behavioral: Music video game |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis NOS
- age 15-45
- able to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music video gameThe video game \'Guitar Hero\' will be used as the platform for training for participants to acquire a new \'skill\' | Behavioural | Active training, Observation training |
Primary outcome
White matter microstructure
Time frame: 3 weeks
fractional anisotropy of white matter tracts as assessed with diffusion tensor imaging
1 secondary outcome
Brain level of N-acetylaspartate
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music video game in people with Schizophrenia Disorders, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua J Chiappelli, MD (4104026827, jchiappe@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White matter microstructure (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.