NCT06208176Not yet recruiting
HD-tDCS for Hallucinations
Targeting Multimodal Hallucinations With fMRI-guided High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Schizophrenia
Source: ClinicalTrials.gov · Last updated 17 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
One in three patients with schizophrenia experiences hallucinations that are refractory to conventional pharmacotherapy. For refractory auditory hallucinations, transcranial direct current stimulation -tDCS- has been proposed as a novel therapeutic approach. Although promising beneficial effects on auditory hallucinations have been found by targeting the left frontal and temporoparietal cortex, the high variability observed in clinical response leaves much room for optimizing stimulation parameters. For instance, options should go beyond the left temporoparietal junction as a unique and single target of hallucinations, taking into account the personalization of the targeting based on the actual brain networks involved in hallucinations, including those beyond the auditory modality, as well as multimodal hallucinations. The present study will take advantage of recent technological developments to propose a personalized therapeutic strategy to alleviate hallucinations in schizophrenia. This will involve: * the simultaneous targeting of multiple brain regions with High-Definition (HD)-tDCS, which is known for its precise and longer-lasting effects compared to conventional tDCS. * and the fMRI-capture of hallucinations, using a precise and reliable data-driven approach to identify the functional brain networks recruited during hallucinations. The aim of the study is to assess whether repeated sessions of HD-tDCS guided using the fMRI capture of hallucinations can reduce multimodal hallucinations in patients with schizophrenia, compared to sham sessions of HD-tDCS.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 12 Dec 2023
- Start date
- Feb 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- Hôpital le Vinatier
- Diseases
- Schizophrenia
- NCT number
- NCT06208176
What you commit to
- Study type: Interventional
- Planned participants: 46
- From Feb 2024 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hallucinogenic drugs
Other illness
- 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)
- 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)
- A clinical condition requiring inpatient procedure under constraint
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Le Vinatier Coordinator of this site? Confirm its status | Bron | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.