Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia (DBS-R)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Deep Brain Stimulation; Treatment-resistant Schizophrenia
• Intervention / Treatment: Device: On-Stimulation; Device: Off-Stimulation

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 Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Department of Psychiatry. Hospital Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Questionnaire about the Process of Recovery (QPR)	Scale to assess personal recovery changes	Changes from baseline total score to 1-12 months total scores
Rosenberg Self-Esteem Scale (RSES)	Scale to assess a person's global self-esteem	Changes from baseline total score to 12 months total scores
Herth Hope Index (HHI)	Scale to assess hope	Changes from baseline total score to 12 months total scores
Internalized stigma of mental illness scale (ISMI)	Scale to assess insight	Changes from baseline total score to 12 months total scores
Beck Cognitive Insight Scale (BCIS)	Scale to assess cognitive insight	Changes from baseline total score to 12 months total scores
Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)	Scale to assess psychological reactions to psychosis	Changes from baseline total score to 12 months total scores
Trail Making Test (TMT A & B)	Scale to assess executive function	Changes from baseline score to 12 months score.
Rey Auditory Verbal Learning Test (RAVLT)	Scale to assess short-term auditory-verbal memory	Changes from baseline score to 12 months score.
F-A-S Test	Scale to assess verbal fluency	Changes from baseline score to 12 months score.
Wisconsin Card Sorting Test (WCST)	Scale to assess cognitive flexibility and abstract reasoning	Changes from baseline score to 12 months score.
Personal and Social Performance scale (PSP)	Scale to assess changes in functioning	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
EuroQol 5 dimensions-5 levels (EQ-5D-5L)	Scales to asses the patient quality of life	Changes from baseline score to 1-12 months scores
Client Satisfaction Questionnaire-8 (CSQ-8)	Scales to asses the satisfaction with the treatment	Changes from baseline score to 12 months score.
Scale for the Assessment of Negative Symptoms (SANS)	Scales to assess negative symptoms of schizophrenia	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Clinical Global Impression - Schizophrenia (CGI-SCH)	Scale to assess the severity of disorder and the degree of change in patients	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Starkstein Apathy Scale (SAS)	Scale to assess apathy	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Depression Inventory (BDI)	Scale to assess depression	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Anxiety Inventory (BAI)	Scale to assess anxiety	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Global Assessment of Functioning (GAF)	Scale to rate how serious a mental disorder may be	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Side Effect Rating Scale (UKU)	Scale to rate side effects	Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Iluminada Corripio, PhD, Department of Psychiatry. Hospital Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Recovery; Deep brain stimulation
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia, Treatment-Resistant; Schizophrenia
• Other Study ID Numbers: IIBSP-ECP-2019-98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No