HD-tDCS for Hallucinations

NCT06208176 | Not Yet Recruiting

• 1 other identifier: 2023-A01629-36
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Hallucinations

Keywords

schizophrenia; non-invasive brain stimulation; fMRI; HD-tDCS; hallucinations

Outcome Measures

Primary Outcomes (1)

• Changes in hallucinations

  Comparison between the active HD-tDCS group and the sham HD-tDCS group of the change in multimodal hallucinations between baseline (V1, within 1 week before the first HD-tDCS session) and after the 20 HD-tDCS sessions (V2, within 1 week of the last HD-tDCS session). Change in hallucinations will be measured as the percentage change in score on the Psychosensory Hallucination Scale

  6 months

Secondary Outcomes (5)

• Long-term changes in hallucinations

  6 months

• Change in symptoms of schizophrenia

  6 months

• Change in social functioning

  6 months

• Changes in source-monitoring performance

  6 months

• Changes in brain connectivity

  6 months

Study Arms (2)

active stimulation group

ACTIVE COMPARATOR

23 patients will receive 20 sessions of active HD-tDCS

Procedure: High-definition transcranial direct current (HD-tDCS), active condition

placebo stimulation group

PLACEBO COMPARATOR

High-definition transcranial direct current (HD-tDCS), sham condition

Procedure: High-definition transcranial direct current (HD-tDCS), sham condition

Interventions

High-definition transcranial direct current (HD-tDCS), active condition PROCEDURE

Patients will receive 20 sessions of active HD-tDCS for a duration of 20min. Sessions will be delivered twice-daily over 2 weeks on the 5 consecutive working days. The number of electrodes used, electrode placement on the scalp (based on EEG 10/10), and the individual currents that need to be injected from each electrode will be determined based on the brain networks identified as involved in their hallucinations during a fMRI acquisition performed at baseline, and computed using a neurotargeting software that allows determining optimal electrode montages for achieving maximal brain current flow in the targeted brain region.

active stimulation group

High-definition transcranial direct current (HD-tDCS), sham condition PROCEDURE

Participants will receive 20 sessions of sham HD-tDCS, which will be delivered following the same procedures as active HD-tDCS. However, stimulation will only be administered in the initial 30 seconds of the 20-minute period, with no further stimulation during the remaining duration. This approach aims to replicate the tingling sensation commonly associated with active stimulation.

placebo stimulation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Pregnancy (controlled by urine pregnancy test in women of childbearing potential) or breastfeeding
• A clinical condition requiring inpatient procedure under constraint

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marine Mondino

CONTACT

04.37.91.15.65; marine.mondino@ch-le-vinatier.fr

Jérôme Brunelin

CONTACT

04.37.91.55.65; Jerome.brunelin@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and experimenters (including tDCS operator) will not be informed about the nature (active or sham) of the stimulation they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 by the fMRI-capture of hallucinations. Arm two is the blinded repeated sham HD-tDCS guided by the fMRI-capture of hallucinations

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 17, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: January 17, 2024

Record last verified: 2023-12

Locations

FR (1)