Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation Applied Pre-cognitive Behavioral Therapy for Psychosis) Associated to Usual Medication Regimen

Summary

The investigators are proposing a new, non-invasive therapeutic model using transcranial alternative current stimulation (tACS), to augment cognitive behavioral therapy for psychosis (CBTp) efficacy in individuals with schizophrenia (SZ). Using EEG brain oscillation activity, as a biomarker of the progression of cognitive deficits in SZ, the investigators aim to understand if addressing the oscillation perturbations could reduce the cognitive deficits. The investigators are using heart rate variability (HRV) as a biomarker of improvement of somatic and mental health. The investigators are aiming also for an analysis through a GBA+ lens, by using along with specific tests for psychosis (PANSS, NSA-16, etc.), the BEM Sex Role Inventory. Considering that cognitive and emotional status is gender dependent, the investigators expect that the therapeutic response could be gender specific. This is a prospective, randomized, repeated-measures, single-blind study design. Pre-intervention, eligible participants will be randomly assigned to one of two treatment arms. Arm 1 (tACS/CBTp n=14); Arm 2 (sham tACS/CBTp, n=14; tACS is sham, but CBTp is active). Intervention (16 weeks): participants in Arms 1 and 2 will receive once weekly tACS/ CBTp or sham tACS/CBTp. Post-intervention: follow-up visits at 4- and 12-weeks post-intervention (with a tACS/CBTp booster session provided each time). The chart review will search for: comorbid metabolic conditions, lab work abnormalities (glycemic level, Hb A, cholesterol), substances use, BMI, type of medication, side effects. Expected outcomes: Participants in Arm 1 will show a better improvement in psychosocial assessment scores, electrical brain activity (tendency to organize the neural oscillations in the gamma frequency range, mainly in frontal lobes) and heart activity (increased HRV). The timeline for recruitment, treatment and follow-up, is 18 months, followed by six months for data analysis, dissemination activities. Population: Individuals with SZ (DSM V criteria) stratified by age and sex. The investigators expect 150 potentially eligible patients from PCH-MHS, with 28 participants consenting to participate.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

OTHER

Experimental: tASC/CBTp: gamma band electric stimulation for 20 minutes at the beginning of the CBTp session

For the transcranial stimulation we will use the tES device from NeuroMyst,. The gamma pulses are delivered to a study participant via stimulating electrodes positioned at participant's head according to the required technique. The tACS will be applied the first 20 minutes from the classic CBTp session for the experimental group.

OTHER

Sham Comparator

For the Sham group the investigators will use the same tES device from NeuroMyst. The Sham stimulation will be applied only for a few seconds in Sham group. The CBTp will follow the same protocol for both arms.

Sponsors & Collaborators

• Providence Care Hospital - Providence Care

  collaborator UNKNOWN

• Queen's University

  collaborator OTHER

• Felicia Iftene

  lead OTHER

Principal Investigators

• Felicia Iftene, Associate Professor, Md, PhD · Department of Psychiatry, Queen's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-24

Primary Completion

2026-06-01

Completion

2027-06-01

Countries

• Canada

Study Locations