Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

Not Applicable

• Conditions: Treatment-resistant Schizophrenia; Deep Brain Stimulation
• Interventions: Device: Off-Stimulation; Device: On-Stimulation

• Registration Number: NCT05337904
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).

Detailed Description

The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies .

Moreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are:

i) to optimizethe efficacy and tolerability of DBS in TRS;

ii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Individuals aged 18-50 years
• Meet DSM-5 criteria for schizophrenia, with a duration of illness < than 15 years.
• Meet updated TRS criteria.
• Non-sustained response to electroconvulsive therapy.

Exclusion Criteria

• Contraindications to neurosurgery or DBS
• Epilepsy or seizures clozapine-induced
• Suicidal or self-harming behaviour in the last 6 months
• Other psychiatric disorders (including personality disorders)
• Significant cognitive impairment (Vocabulary test WAIS IV-TR, IQ <70, and SCIP<55)
• Severe medical non-controlled diseases
• Pregnancy or breastfeeding
• Substance use disorders (except nicotine)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Off-Stimulation	Off-Stimulation	Disease condition is assessed with stimulation turned "off"
On-Stimulation	On-Stimulation	Disease condition is assessed with stimulation turned "on"

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)	Scale to assess changes in schizophrenia' symptoms

Secondary Outcome Measures

Name	Time	Method
Cognitive Outcomes	Changes from baseline score to 12 months score.	Battery of neuropsychological tests to assess changes in cognition
Functioning Outcomes	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores	Scales to assess changes in functioning
Well-being Outcomes	Changes from baseline score to 1-12 months scores	Scales to asses the patient quality of life
Satisfaction Outcomes	Changes from baseline score to 12 months score.	Scales to asses the satisfaction with the treatment
Clinical Recovery Outcomes	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores	Scales to asses changes in schizophrenia symptoms throughout the study.
Personal Recovery Outcomes	Changes from baseline score to 1-12 months scores	Scales to assess personal recovery changes

Trial Locations

Locations (1)

Department of Psychiatry. Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain