Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

Deep Brain Stimulation Clinical Trial

— DBS-R  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337904
• Other study ID #: IIBSP-ECP-2019-98
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Sandra Roldan, PhD
• Phone: +34 93 553 78 40
• Email: ARoldanB[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Schizophrenia
• Treatment-resistant Schizophrenia

Intervention

Device:
• On-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
• Off-Stimulation
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".

Locations

Country	Name	City	State
Spain	Department of Psychiatry. Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	Scale to assess changes in schizophrenia' symptoms	Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Secondary	Clinical Recovery Outcomes	Scales to asses changes in schizophrenia symptoms throughout the study.	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Secondary	Personal Recovery Outcomes	Scales to assess personal recovery changes	Changes from baseline score to 1-12 months scores
Secondary	Cognitive Outcomes	Battery of neuropsychological tests to assess changes in cognition	Changes from baseline score to 12 months score.
Secondary	Functioning Outcomes	Scales to assess changes in functioning	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Secondary	Well-being Outcomes	Scales to asses the patient quality of life	Changes from baseline score to 1-12 months scores
Secondary	Satisfaction Outcomes	Scales to asses the satisfaction with the treatment	Changes from baseline score to 12 months score.