Using brain stimulation to treat resistant auditory hallucinations in schizophrenia
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
NA · Centre hospitalier de Ville-Evrard, France · NCT04352569
This study is testing whether a type of brain stimulation can help people with schizophrenia who have persistent auditory hallucinations feel better when other treatments haven't worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de Ville-Evrard, France (other) |
| Locations | 1 site (Neuilly Sur Marne) |
| Trial ID | NCT04352569 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of transcranial direct current stimulation (tDCS) in treating auditory hallucinations in patients with schizophrenia who have not responded to standard treatments. It employs a randomized, double-blind, placebo-controlled design, where participants will receive either active or placebo tDCS sessions twice daily for two weeks. The study aims to assess not only the effectiveness of tDCS on hallucinations but also its impact on overall schizophrenia symptoms and patients' quality of life. Additionally, it will measure changes in brain-derived neurotrophic factor (BDNF) levels to understand the neurocognitive effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates are right-handed individuals diagnosed with schizophrenia who experience refractory auditory hallucinations despite trials of at least two antipsychotic medications.
Not a fit: Patients with other psychiatric disorders, severe head trauma, epilepsy, or those with intracranial metallic objects will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, non-invasive option for patients suffering from resistant auditory hallucinations.
How similar studies have performed: Previous studies have shown promising results for tDCS in treating auditory hallucinations, suggesting potential efficacy in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Schizophrenia according to DSM-V. * Refractory auditory hallucinations(despite two antipsychotics trials). * Right-handed patients. * Written informed consent. Exclusion Criteria: * Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ). * History of severe head trauma or coma. * History of epilepsy or neurological disorder or a general medical condition. * Presence of intracranial metallic objects or pacemaker. * Hospitalized patients without consent. * pregnant women .
Where this trial is running
Neuilly Sur Marne
- unité de recherche clinique de l'E.P.S de Ville Evrard — Neuilly Sur Marne, France (RECRUITING)
Study contacts
- Principal investigator: NOOMANE BOUAZIZ, MD — Unité de Recherche Clinique de l'EPS de Ville Evard
- Study coordinator: Rusheenthira THAVASEELAN, Msc
- Email: r.thavaseelan@epsve.fr
- Phone: 0143093232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Hallucinations, Refractory Schizophrenia