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: 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 (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Roldan, PhD; Phone Number: +34 93 553 78 40; Email: ARoldanB@santpau.cat
• Study Contact Backup: Name: Eva M Grasa, PhD; Phone Number: +34 93 553 78 40; Email: egrasa@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Department of Psychiatry. Hospital Santa Creu i Sant Pau
    • Contact: Eva M Grasa, PhD; Phone Number: +34 93 553 78 40; Email: egrasa@santpau.cat
    • Contact: Iluminada MD Corripio, PhD; Phone Number: +34 93 553 78 40; Email: icorripio@santpau.cat

Participation Criteria

Eligibility Criteria

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

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
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.

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): January 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 31, 2023

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): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Recovery; Deep brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; 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