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NCT Number: NCT06208176

HD-tDCS for Hallucinations

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier le Vinatier

Bron, 69678, France

About this study

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 hallucinations (20 sessions of stimulation over 10 days, 20 min/session). Arm two is the blinded sham repeated HD-tDCS guided by the fMRI-capture of hallucinations (20 sessions of sham stimulation over 10 days, 20 min/session).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in hallucinations

    Time frame: 6 months

    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

Secondary outcomes

  1. Long-term changes in hallucinations

    Time frame: 6 months

    Comparisons between active and sham HD-tDCS groups of the change in multimodal hallucinations (assessed with the PSAS, in percent) between baseline and follow-up assessments at one month and three months after the 20 sessions of HD-tDCS.

  2. Change in symptoms of schizophrenia

    Time frame: 6 months

    Comparisons between active and sham HD-tDCS groups of the change in other symptoms of schizophrenia between baseline (V1, within 1 week before first stimulation) and post-intervention (V2, within 1 week after last stimulation), and follow-up assessments (V3: at one month, V4: at 3 months). Symptoms of schizophrenia will be measured by the total score at the Positive and Negative Syndrome Scale - PANSS , and by the scores in the five subdimensions of the PANSS (positive, negative, depression, disorganization, and grandiosity/excitement).

  3. Change in social functioning

    Time frame: 6 months

    Comparisons between active and sham HD-tDCS groups of change in social functioning measured by the Social and Occupational Functioning Assessment Scale - SOFAS (Goldman et al., 1992) between baseline (V1, within 1 week before first stimulation) and follow-up assessments, one month (V3) and three months (V4) after the intervention

  4. Changes in source-monitoring performance

    Time frame: 6 months

    Source monitoring performance will be evaluated using a specific source monitoring task. Source-monitoring accuracy scores (range 0-100) will be calculated as proportions of accurate source attributions for each source

  5. Changes in brain connectivity

    Time frame: 6 months

    Comparisons between active and sham HD-tDCS groups of changes in brain connectivity within the hallucination-related network, measured with fMRI

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Brunelin

CONTACT

[email protected]

04.37.91.55.65 ext. +33

Marine Mondino

CONTACT

[email protected]

04.37.91.15.65 ext. +33

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Targeting Multimodal Hallucinations With fMRI-guided High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Schizophrenia

Acronym: TARGET

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2024
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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