Status:
NOT_YET_RECRUITING
HD-tDCS for Hallucinations
Lead Sponsor:
Hôpital le Vinatier
Conditions:
Schizophrenia
Hallucinations
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
One in three patients with schizophrenia experiences hallucinations that are refractory to conventional pharmacotherapy. For refractory auditory hallucinations, transcranial direct current stimulation...
Detailed Description
The study is a multicentre, prospective, randomised, double-blind, parallel group, sham-controlled, two-arm clinical trial. Arm one is repeated active HD-tDCS guided using the fMRI-capture of hallucin...
Eligibility Criteria
Inclusion
- Females and males aged between 18 and 50
- Diagnosis of schizophrenia according to DSM 5.0 criteria
- Presence of dailyfrequent hallucinations (\> 2 / hour) despite the optimization of the antipsychotic dosage and molecule (based on the prescriber's judgment) for at least 6 weeks. The presence of such daily frequent refractory hallucinations will be operationalized by an interview with a trained psychiatrist.
- Patient under curatorship/guardianship or not
- Covered by a public health insurance
- Understanding French language
- Signed written informed consent after being informed about the study
Exclusion
- Other disabling Axis Inpsychiatric conditions including a current diagnosis of a major depressive episode (uni- or bi- polar disorder) according to DSM 5, and substance use disorder (except tobacco)
- Use of hallucinogenic drugs
- Contraindications for magnetic resonance imaging or tDCS (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes, cochlear implants, severe claustrophobia)
- Changes in the total PSAS and PANSS score of at least 15% between screening/inclusion (T0) and baseline visits (T1). This criterion will ensure the stability of symptoms before treatment.
- Pregnancy (controlled by urine pregnancy test in women of childbearing potential) or breastfeeding
- A clinical condition requiring inpatient procedure under constraint
Key Trial Info
Start Date :
February 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06208176
Start Date
February 28 2024
End Date
July 30 2028
Last Update
January 17 2024
Active Locations (1)
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1
Centre Hospitalier le Vinatier
Bron, France, 69678