Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

Last updated: April 13, 2022
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psychosis

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT05337904
IIBSP-ECP-2019-98
  • Ages 18-50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 6
Study Start date:
January 01, 2021
Estimated Completion Date:
December 31, 2023

Study 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

Connect with a study center

  • Department of Psychiatry. Hospital Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.