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 (NCT06889025)
Electric and Physiological Markers, Underlying Mechanisms and Modulation of Cognitive Functioning and Therapeutic Improvement in Response to tACS/CBTp (Transcranial Alternating Current Stimulation Applied at the Beginning of the Cognitive Behavioral Therapy for Psychosis Session) in Combination With the Usual Pharmacological Treatment in Schizophrenia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Providence Care Hospital — Kingston, Ontario
Age range: 18 Years
🧪 Interventions in This Study
- Experimental: tASC/CBTp: gamma band electric stimulation for 20 minutes at the beginning of the CBTp session (OTHER)
- Sham Comparator (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Providence Care Hospital — Kingston, Ontario
📞 Contact the Study Coordinator
Phone: (613) 484-7330
Email: iftenef@providencecare.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Schizophrenia
- Young Adults With Violent Behavior During Early Psychosis (Aim 2) — New York, New York
- Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia — Toronto, Ontario
- Ketogenic Diet in People With Schizophrenia — Catonsville, Maryland
- Paired Associative Stimulation in the Dorsolateral Prefrontal Cortex in Patients With Schizophrenia — Toronto, Ontario
- Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography — Toronto, Ontario
- Long-Term Real-World Safety of Cobenfy in Adults With Schizophrenia — Suwanee, Georgia
Explore by condition: All Schizophrenia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.