This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.
The first phase of the study will consist of implanting electrodes. Recruited patients will be random to 2 targets: (1) medial prefrontal cortex (mPFC); (2) nucleus accumbens (NAcc). Continuous stimulation will be applied until the patients stabilise clinically. This period is anticipated between 6 and 9 months. After this stage, the next phase will consist of the crossover study. Those patients who respond to DBS will be randomly distributed in two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months. Weekly visits during first month after, and fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance. Patients who complete the study and respond to treatment with DBS will be provided continuing with treatment, and keeping control visits to assess the long-term effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"
The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"
FIDMAG Germanes Hospitalàries Research Foundation
Sant Boi de Llobregat, Barcelona, Spain
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Spain
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Scale to assess changes in schizophrenia' symptoms
Time frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Clinical Global Impression-Schizophrenia (CGI-SCH)
Scale to assess changes in schizophrenia symptoms' severity, global improvement or change.
Time frame: Changes from baseline score to 1-12 months scores
Global Functioning Scale (GFS)
Scale to assess changes in social, occupational, and psychological functioning
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Social Functioning Scale (SFS)
Scale to assess changes in social functioning
Time frame: Changes from baseline score to 1-3 weeks scores and to 1-12 months scores
Personal and Social Performance (PSP)
Scale to assess changes in functioning
Time frame: Changes from baseline score to 1-12 months scores
Psychotic Symptom Rating Scales (PSYRATS)
Scale to assess changes in hallucinations
Time frame: Changes from baseline score to 1-12 months scores
Scale for the Assessment of Negative Symptoms (SANS)
Scale to assess changes in negative symptoms of schizophrenia
Time frame: Changes from baseline score to 1-12 months scores
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Calgary Depression Scale for Schizophrenia (CDSS)
Scale to assess changes in depressive symptoms
Time frame: Changes from baseline score to 1-12 months scores
Performance-Based Skills Assessment (UPSA)
Scale to assess changes in functional capacity
Time frame: Changes from baseline score to 12 months score
Neuropsychological Assessment
Battery of neuropsychological tests to assess changes in cognition
Time frame: Changes from baseline score to 12 months score
Cerebral metabolism (PET scans)
Assessment of changes in brain blow flow using the nuclear medicine procedure, PET
Time frame: Changes from baseline scan to 6 and 12 months scans
n-Back (fMRI scan)
Task to measure changes in working memory
Time frame: Changes from baseline scan to 6 and 12 months scans
Adverse events (AEs)
All unexpected medical problem that happens during DBS treatment
Time frame: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)