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

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

Status: Unknown

Conditions: Treatment-resistant Schizophrenia; Deep Brain Stimulation

Treatments: Device: Off-Stimulation; Device: On-Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05337904

IIBSP-ECP-2019-98

Details and patient eligibility

About

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

Full 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

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

6 participants in 2 patient groups, including a placebo group

On-Stimulation

Active Comparator group

Description:

Disease condition is assessed with stimulation turned "on"

Treatment:

Device: On-Stimulation

Off-Stimulation

Placebo Comparator group

Description:

Disease condition is assessed with stimulation turned "off"

Treatment:

Device: Off-Stimulation