Status:
NOT_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
Lead Sponsor:
Felicia Iftene
Collaborating Sponsors:
Providence Care Hospital - Providence Care
Queen's University
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 i...
Detailed Description
Rationale. 1% Canadians suffer from Schizophrenia (SZ), a neurodegenerative condition with a high rate of relapse, and important personal, familial and social burden, involving a high cost for care. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- current illicit drug substance abuse;
- current suicidal ideation;
- current enrollment in CBTp or other formalized psychosocial interventions;
- undergone vagotomy or surgery upon the vagus nerve;
- comorbid neurological condition;
- severe or moderate intellectual disability;
- currently undergoing hormone therapy;
- 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
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06889025
Start Date
July 24 2025
End Date
June 1 2027
Last Update
July 24 2025
Active Locations (1)
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1
Providence Care Hospital
Kingston, Ontario, Canada, K7L7X3