Treatment-resistant SchizophreniaDBS-RNCT05337904
Deep Brain Stimulation Recovery in Treatment-Resistant Schizophrenia
A study testing On-Stimulation and Off-Stimulation in people with Treatment-resistant Schizophrenia and Deep Brain Stimulation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Treatment-resistant Schizophrenia, Deep Brain Stimulation
- What is being tested?
- On-Stimulation and Off-Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Barcelona
About this study
Official title: 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).
Read the 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:
- 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
- Being tested
- On-Stimulation, Off-Stimulation
- Keywords
- Recovery, Deep brain stimulation, Schizophrenia
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-StimulationDevice
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on".
Off-StimulationDevice
The surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off".
| Study group | Role | What they receive |
|---|---|---|
| On-Stimulation | Active comparator | Disease condition is assessed with stimulation turned "on" Receives: Device: On-Stimulation |
| Off-Stimulation | Placebo comparator | Disease condition is assessed with stimulation turned "off" Receives: Device: Off-Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Scale to assess changes in schizophrenia' symptoms
Measured: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Secondary outcomes (20)
Questionnaire about the Process of Recovery (QPR)
Scale to assess personal recovery changes
Measured: 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
Measured: Changes from baseline total score to 12 months total scores
Herth Hope Index (HHI)
Scale to assess hope
Measured: Changes from baseline total score to 12 months total scores
Internalized stigma of mental illness scale (ISMI)
Scale to assess insight
Measured: Changes from baseline total score to 12 months total scores
Beck Cognitive Insight Scale (BCIS)
Scale to assess cognitive insight
Measured: 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
Measured: Changes from baseline total score to 12 months total scores
Trail Making Test (TMT A & B)
Scale to assess executive function
Measured: Changes from baseline score to 12 months score.
Rey Auditory Verbal Learning Test (RAVLT)
Scale to assess short-term auditory-verbal memory
Measured: Changes from baseline score to 12 months score.
F-A-S Test
Scale to assess verbal fluency
Measured: Changes from baseline score to 12 months score.
Wisconsin Card Sorting Test (WCST)
Scale to assess cognitive flexibility and abstract reasoning
Measured: Changes from baseline score to 12 months score.
Personal and Social Performance scale (PSP)
Scale to assess changes in functioning
Measured: 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
Measured: Changes from baseline score to 1-12 months scores
Client Satisfaction Questionnaire-8 (CSQ-8)
Scales to asses the satisfaction with the treatment
Measured: Changes from baseline score to 12 months score.
Scale for the Assessment of Negative Symptoms (SANS)
Scales to assess negative symptoms of schizophrenia
Measured: 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
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Starkstein Apathy Scale (SAS)
Scale to assess apathy
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Depression Inventory (BDI)
Scale to assess depression
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Anxiety Inventory (BAI)
Scale to assess anxiety
Measured: 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
Measured: 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
Measured: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Sep 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant SchizophreniaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iluminada Corripio, PhD, Principal investigator, Department of Psychiatry. Hospital Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337904
- Sponsor's protocol ID
- IIBSP-ECP-2019-98
- Acronym
- DBS-R
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2022
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation: Towards a Novel Intervention Focused on the Recovery of Patients With Treatment-Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT05337904
- Acronym / sponsor ID
- DBS-R / IIBSP-ECP-2019-98
- Keywords
- Recovery, Deep brain stimulation, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A clinical trial with four periods will be performed: pre-treatment, Intervention and follow-up, Cross-over period, and Recoveryoriented intervention.
| Arm | Type | Receives |
|---|---|---|
| On-Stimulation | Active comparator | Device: On-StimulationDisease condition is assessed with stimulation turned "on" |
| Off-Stimulation | Placebo comparator | Device: Off-StimulationDisease condition is assessed with stimulation turned "off" |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-StimulationThe surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "on". | Device | On-Stimulation |
| Off-StimulationThe surgical electrode implanted in target 1 (ACC) or target 2 (NAcc) by a pulse generating device is "off". | Device | Off-Stimulation |
Primary outcome
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
20 secondary outcomes
Questionnaire about the Process of Recovery (QPR)
Time frame: Changes from baseline total score to 1-12 months total scores
Rosenberg Self-Esteem Scale (RSES)
Time frame: Changes from baseline total score to 12 months total scores
Herth Hope Index (HHI)
Time frame: Changes from baseline total score to 12 months total scores
Internalized stigma of mental illness scale (ISMI)
Time frame: Changes from baseline total score to 12 months total scores
Beck Cognitive Insight Scale (BCIS)
Time frame: Changes from baseline total score to 12 months total scores
Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)
Time frame: Changes from baseline total score to 12 months total scores
Trail Making Test (TMT A & B)
Time frame: Changes from baseline score to 12 months score.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Changes from baseline score to 12 months score.
F-A-S Test
Time frame: Changes from baseline score to 12 months score.
Wisconsin Card Sorting Test (WCST)
Time frame: Changes from baseline score to 12 months score.
Personal and Social Performance scale (PSP)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
EuroQol 5 dimensions-5 levels (EQ-5D-5L)
Time frame: Changes from baseline score to 1-12 months scores
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Changes from baseline score to 12 months score.
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
Clinical Global Impression - Schizophrenia (CGI-SCH)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Starkstein Apathy Scale (SAS)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Depression Inventory (BDI)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Beck Anxiety Inventory (BAI)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Global Assessment of Functioning (GAF)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Side Effect Rating Scale (UKU)
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iluminada Corripio, PhD principal investigator
Department of Psychiatry. Hospital Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Stimulation and Off-Stimulation in people with Treatment-resistant Schizophrenia and Deep Brain Stimulation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.