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Externalization and Stimulation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05936307
Acronym
STUPEFIX
Enrollment
30
Registered
2023-07-07
Start date
2024-01-16
Completion date
2025-09-30
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

externalization, auditory processing, reality-monitoring, stimulation, HD-TDCS

Brief summary

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

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.

Interventions

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.

PROCEDUREHigh-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

Sponsors

Hôpital le Vinatier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants and experimenters (including tDCS operator) will not be informed about the nature (active or placebo) of the stimulation they will receive.

Intervention model description

Double-blind, placebo-controlled, randomized crossover study including 30 healthy participants who will receive active and placebo HD-tDCS in a counterbalanced order.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Externalization abilitiesone yearproportion of sounds perceived as coming from an external source in the externalization task (range 0-100%)

Secondary

MeasureTime frameDescription
Reality monitoring performanceone yearScores obtained at the reality monitoring task (Brunelin et al., 2006) (accuracy, range = 0-100%)
Self-agencyone yearPercentage 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)
Psychometric characteristics that may influence externalization abilities and stimulation effectsbaselineLaunay-Slade Hallucinations Scale scores between 0 and 64 (LSHS; Launay and Slade)
Side effects of stimulation1 time before (baseline) and within 1 hour after stimulationScores at the questionnaire on side effects of stimulation. Scores between 10 and 44 (higher scores mean worse outcome)
Mood1 time before (baseline) and within 1 hour after stimulationMood self-questionnaire. Scores between 0 and 100 (higher scores mean worse outcome)

Countries

France

Contacts

Primary ContactMarine MONDINO, PhD
marine.mondino@ch-le-vinatier.fr0437915565
Backup ContactLydie SARTELET
lydie.sartelet@ch-le-vinatier.fr0437915531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026