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Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia

Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05435300
Enrollment
20
Registered
2022-06-28
Start date
2021-09-17
Completion date
2026-09-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective, Schizophrenia

Keywords

Positron emission tomography

Brief summary

This study will examine changes in synaptic density with transcranial direct current stimulation (tDCS) in the brains of patients with schizophrenia. Synaptic density levels will be measured using a novel positron emission tomography (PET) radiotracer \[18F\]SDM-8, which is currently the best-in-class method to quantify synaptic density in humans. This will be a companion study to a parent study by our group examining the effects of tDCS on treatment adherence in schizophrenia (REB #103-2018).

Detailed description

The aim of our study is to examine if tDCS induces synaptic density changes in patients with schizophrenia using \[18F\]SDM-8. Our study will help elucidate the mechanism through which tDCS affects the brain. PET scans will be offered to participants that meet the inclusion and exclusion criteria at the initial screening visit. Participants will be scanned with the novel PET tracer \[18F\]SDM-8 to quantify synaptic density levels. PET scans will be timed to coincide to the two time-points, before and after 2-weeks of tDCS treatment that is completed under the parent study protocol (REB #103-2018). Clinical assessments will be done at the same time.

Interventions

OTHERPET Scan

Participants will undergo two PET scans throughout the study.

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Enrolment in the tDCS-adherence parent study (REB# 103-2018). The parent study inclusion criteria are: 1. Male or female participants of any race or ethnicity 2. Inpatients or outpatients ≥18 years of age 3. DSM-V diagnosis of schizophrenia or schizoaffective disorder 4. Capable of consenting to participate in the research study 5. On a stable dose of oral antipsychotic drug and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study.

Exclusion criteria

The

Design outcomes

Primary

MeasureTime frameDescription
Synaptic density changesPET scans will be timed to coincide to the two time-points, before and after 2-weeks of tDCS treatment that is completed under the parent study protocol (REB #103-2018)The primary outcome measure is the \[18F\]SDM-8 standard uptake value (SUV) and distribution volume ratio (DVR) in cortical and subcortical gray matter regions, measured by PET Scans

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORPhilip Gerretsen, MD, PhD

Centre for Addiction and Mental Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026