NCT05337904

Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

Deep Brain Stimulation: Towards a Novel Intervention Focused on the Recovery of Patients With Treatment-Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Treatment-resistant Schizophrenia
• Deep Brain Stimulation

Interventions

Type	Name	Description
DEVICE	On-Stimulation	The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
DEVICE	Off-Stimulation	The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-03-01
• Completion: 2026-07-31
• First posted: 2022-04-20
• Last updated: 2025-07-29

Locations

1 site across 1 country: Spain