NCT06889025Not yet recruiting
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
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Felicia Iftene
- Diseases
- Schizophrenia
- NCT number
- NCT06889025
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 24 Jul 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current illicit drug substance abuse;
- undergone vagotomy or surgery upon the vagus nerve;
- currently undergoing hormone therapy;
Other illness
- comorbid neurological condition;
Lab values
- under age 18.
- NOTE: changes in medication/new hospitalization for worsening symptoms and/or presence of suicidal ideation are no more exclusion criteria for subjects that have passed visit 5 (end of intervention, during follow-ups stage); however the results of the follow-up visits will count at the final results, depending on the severity/imminent danger of symptoms and medication changes, at the best judgment of the principal investigator
Other
- current suicidal ideation;
- current enrollment in CBTp or other formalized psychosocial interventions;
- severe or moderate intellectual disability;
Who the study is looking for
- Individuals, with at least 5 years duration of illness, that meet diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual for Mental Disorders-5 and at least one residual positive symptom (as determined by the referring physician);
- no change in medication regimen for at least 1 months (minor dose adjustments and/or change in medication involving symptoms as sleep, anxiety or medical symptoms such as fever, pain, are permitted);
- all genders between ages 18-65 (participants 65+ may be eligible depending on performance on cognitive assessment);
- ability to understand English with reading level at or above grade 6;
- able to understand and comply with the requirements of the study;
- provision of written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence care Hospital Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.