Externalization and Stimulation (STUPEFIX)

March 6, 2024 updated by: Hôpital le Vinatier

Modulation of Auditory Externalization Abilities by Transcranial Stimulation of the Brain Area Specifically Involved

The distinction between self-generated and external information is impaired in patients with schizophrenia, who are assumed to confuse imagination with real perceptions. To better understand the underlying mechanisms of these abnormalities, the investigator will investigate the brain mechanisms supporting auditory externalization. Auditory externalization is the ability to perceive whether a sound comes from inside or outside oneself. Our study, in healthy participants, will use functional brain imaging to identify the brain areas involved in the externalization of sound sources and to test whether neuromodulation of this area can modify this ability and provide a therapeutic lead in pathological populations

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

30 healthy participants will be included. The participants will undergo three separate visits. During the first one, the participants will listen to sounds coming from either internal or external sources while undergoing an fMRI session. This will allow us to identify the brain region involved in externalizing abilities with the highest activity. In the second and third visits, this specific region will be targeted by HD-tDCS (a non-invasive high-definition neuromodulation technique whose precision is enhanced by individual data) to modulate its activity and test its causal involvement in externalization processes. Each participant will receive both active and placebo stimulation, with the order counterbalanced. During the stimulation, participants will complete an externalization task, followed by a reality monitoring task and a self-agency task. Additionally, the investigator will gather socio-demographic and psychometric data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69678
        • Recruiting
        • Centre Hospitalier Le Vinatier
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jerome Brunelin
        • Principal Investigator:
          • Marine Mondino
        • Sub-Investigator:
          • Frédéric Haesebaert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having given their written informed consent
  • Affiliated with a social security scheme
  • French speakers and readers

Exclusion Criteria:

  • With contraindication to HD-tDCS stimulation or fMRI
  • With a history of or current hearing problems, including tinnitus
  • Taking medication (except contraceptives)
  • With a history of or current psychiatric diagnosis (DSM-5 criteria)
  • First-degree relatives with a diagnosis of schizophrenia spectrum disorder or bipolar disorder (DSM5)
  • Have a personal history of neurological disorders or head trauma with loss of consciousness
  • With an intellectual disability (Raven's Matrices)
  • With developed musical abilities (i.e., regular practice of a musical instrument for at least 10 years with assiduity or at a music school or conservatory)
  • Pregnant or nursing
  • Being in a period of exclusion and/or having exceeded the annual indemnity ceiling (€4,500) for other clinical research.
  • Under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 15 healthy participants active then placebo
15 healthy participants will receive a session of active HD-tDCS and then a session of placebo HD-tDCS.
Procedure: High-definition transcranial direct current (HD-tDCS), active condition
Participants will receive a session of active HD-tDCS at a current intensity of 2 mA for a duration of 25min. The placement of electrodes will be determined to specifically target the brain area that has been identified as being involved in the process of externalization, as evidenced by fMRI. During the stimulation, participants will be engaged in a computer-based externalization task.
Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition

Participants will receive a session of placebo HD-tDCS, which will be delivered following the same procedures as active HD-tDCS but the intensity of the current will be set at 2mA during the 30 first seconds at the beginning of the 25-min period of the stimulation, and equal to 0 mA for the reminding period of stimulation to simulate the tingling sensation often experienced by individuals during active stimulation.

The placement of electrodes will be determined to specifically target the brain area that has been identified as being involved in the process of externalization, as evidenced by fMRI. During the stimulation, participants will be engaged in a computer-based externalization task
Placebo Comparator: 15 healthy participants placebo then active
15 healthy participants will receive a session of placebo HD-tDCS and then a session of active HD-tDCS.
Procedure: High-definition transcranial direct current (HD-tDCS), active condition
Participants will receive a session of active HD-tDCS at a current intensity of 2 mA for a duration of 25min. The placement of electrodes will be determined to specifically target the brain area that has been identified as being involved in the process of externalization, as evidenced by fMRI. During the stimulation, participants will be engaged in a computer-based externalization task.
Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition

Participants will receive a session of placebo HD-tDCS, which will be delivered following the same procedures as active HD-tDCS but the intensity of the current will be set at 2mA during the 30 first seconds at the beginning of the 25-min period of the stimulation, and equal to 0 mA for the reminding period of stimulation to simulate the tingling sensation often experienced by individuals during active stimulation.

The placement of electrodes will be determined to specifically target the brain area that has been identified as being involved in the process of externalization, as evidenced by fMRI. During the stimulation, participants will be engaged in a computer-based externalization task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Externalization abilities
Time Frame: one year
proportion of sounds perceived as coming from an external source in the externalization task (range 0-100%)
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reality monitoring performance
Time Frame: one year
Scores obtained at the reality monitoring task (Brunelin et al., 2006) (accuracy, range = 0-100%)
one year
Self-agency
Time Frame: one year
Percentage of voice deviation in the self-agency task (Subramaniam et al., 2018) (pitch perturbation and variability in peak deviation in cents, cents(t) = 1200 log2 (Hertz(t )/HertzRef), mean pitch perturbation response tracks = ±100 and ± 400)
one year
Psychometric characteristics that may influence externalization abilities and stimulation effects
Time Frame: baseline
Launay-Slade Hallucinations Scale scores between 0 and 64 (LSHS; Launay and Slade)
baseline
Psychometric characteristics that may influence externalization abilities and stimulation effects
Time Frame: baseline
Plymouth Sensory Imagery Questionnaire (PSIQ).Scores between 0 and 70.
baseline
Side effects of stimulation
Time Frame: 1 time before (baseline) and within 1 hour after stimulation
Scores at the questionnaire on side effects of stimulation. Scores between 10 and 44 (higher scores mean worse outcome)
1 time before (baseline) and within 1 hour after stimulation
Mood
Time Frame: 1 time before (baseline) and within 1 hour after stimulation
Mood self-questionnaire. Scores between 0 and 100 (higher scores mean worse outcome)
1 time before (baseline) and within 1 hour after stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital le Vinatier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marine MONDINO, Phd, hospital le vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-A00452-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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