Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

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

Detailed Description
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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

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

Conditions
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Treatment-resistant Schizophrenia, Deep Brain Stimulation

Intervention / Treatment
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* Device: On-Stimulation
* Device: Off-Stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On-Stimulation<br>Disease condition is assessed with stimulation turned on | Device: On-Stimulation<br>* The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is on.<br>|
| Placebo Comparator: Off-Stimulation<br>Disease condition is assessed with stimulation turned off | Device: Off-Stimulation<br>* The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Personal Recovery Outcomes | Scales to assess personal recovery changes | Changes from baseline score to 1-12 months scores | 
| Cognitive Outcomes | Battery of neuropsychological tests to assess changes in cognition | Changes from baseline score to 12 months score. | 
| Functioning Outcomes | Scales to assess changes in functioning | Changes from baseline score to 1-3 weeks scores and to 1-12 months scores | 
| Well-being Outcomes | Scales to asses the patient quality of life | Changes from baseline score to 1-12 months scores | 
| Satisfaction Outcomes | Scales to asses the satisfaction with the treatment | Changes from baseline score to 12 months score. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recovery, Deep brain stimulation, Schizophrenia