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Active, Not Recruiting

NCT Number: NCT05337904

Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Treatment-resistant Schizophrenia Deep Brain Stimulation Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

On-Stimulation

Device

The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".

Off-Stimulation

Device

The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".

Primary outcomes

  1. Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

    Time frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

    Scale to assess changes in schizophrenia' symptoms

Secondary outcomes

  1. Questionnaire about the Process of Recovery (QPR)

    Time frame: Changes from baseline total score to 1-12 months total scores

    Scale to assess personal recovery changes

  2. Rosenberg Self-Esteem Scale (RSES)

    Time frame: Changes from baseline total score to 12 months total scores

    Scale to assess a person's global self-esteem

  3. Herth Hope Index (HHI)

    Time frame: Changes from baseline total score to 12 months total scores

    Scale to assess hope

  4. Internalized stigma of mental illness scale (ISMI)

    Time frame: Changes from baseline total score to 12 months total scores

    Scale to assess insight

  5. Beck Cognitive Insight Scale (BCIS)

    Time frame: Changes from baseline total score to 12 months total scores

    Scale to assess cognitive insight

  6. Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)

    Time frame: Changes from baseline total score to 12 months total scores

    Scale to assess psychological reactions to psychosis

  7. Trail Making Test (TMT A & B)

    Time frame: Changes from baseline score to 12 months score.

    Scale to assess executive function

  8. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Changes from baseline score to 12 months score.

    Scale to assess short-term auditory-verbal memory

  9. F-A-S Test

    Time frame: Changes from baseline score to 12 months score.

    Scale to assess verbal fluency

  10. Wisconsin Card Sorting Test (WCST)

    Time frame: Changes from baseline score to 12 months score.

    Scale to assess cognitive flexibility and abstract reasoning

  11. Personal and Social Performance scale (PSP)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to assess changes in functioning

  12. EuroQol 5 dimensions-5 levels (EQ-5D-5L)

    Time frame: Changes from baseline score to 1-12 months scores

    Scales to asses the patient quality of life

  13. Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: Changes from baseline score to 12 months score.

    Scales to asses the satisfaction with the treatment

  14. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scales to assess negative symptoms of schizophrenia

  15. Clinical Global Impression - Schizophrenia (CGI-SCH)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to assess the severity of disorder and the degree of change in patients

  16. Starkstein Apathy Scale (SAS)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to assess apathy

  17. Beck Depression Inventory (BDI)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to assess depression

  18. Beck Anxiety Inventory (BAI)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to assess anxiety

  19. Global Assessment of Functioning (GAF)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to rate how serious a mental disorder may be

  20. Side Effect Rating Scale (UKU)

    Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

    Scale to rate side effects

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: DBS-R

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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