Healthy ParticipantsSTUPEFIXNCT05936307
Externalization and Stimulation
A study testing High-definition transcranial direct current (HD-tDCS), active condition in people with Healthy Participants, run by Hôpital le Vinatier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- High-definition transcranial direct current (HD-tDCS), active condition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having given their written informed consent
- Affiliated with a social security scheme
- French speakers and readers
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier le Vinatier
Bron, 69678
Marine Mondino, 0437915565 ext. +33, marine.mondino@ch-le-vinatier.fr
Jérôme Brunelin, 0437915297 ext. +33, jerome.brunelin@ch-le-vinatier.fr
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- High-definition transcranial direct current (HD-tDCS), active condition, High-definition transcranial direct current (HD-tDCS), placebo condition
- Keywords
- externalization, auditory processing, reality-monitoring, stimulation, HD-TDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition transcranial direct current (HD-tDCS), active conditionProcedure or surgery
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.
High-definition transcranial direct current (HD-tDCS), placebo conditionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 15 healthy participants active then placebo | Active comparator | 15 healthy participants will receive a session of active HD-tDCS and then a session of placebo HD-tDCS. Receives: Procedure: High-definition transcranial direct current (HD-tDCS), active condition; Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition |
| 15 healthy participants placebo then active | Placebo comparator | 15 healthy participants will receive a session of placebo HD-tDCS and then a session of active HD-tDCS. Receives: Procedure: High-definition transcranial direct current (HD-tDCS), active condition; Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Externalization abilities
proportion of sounds perceived as coming from an external source in the externalization task (range 0-100%)
Measured: one year
Secondary outcomes (6)
Reality monitoring performance
Scores obtained at the reality monitoring task (Brunelin et al., 2006) (accuracy, range = 0-100%)
Measured: one year
Self-agency
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)
Measured: one year
Psychometric characteristics that may influence externalization abilities and stimulation effects
Launay-Slade Hallucinations Scale scores between 0 and 64 (LSHS; Launay and Slade)
Measured: baseline
Psychometric characteristics that may influence externalization abilities and stimulation effects
Plymouth Sensory Imagery Questionnaire (PSIQ).Scores between 0 and 70.
Measured: baseline
Side effects of stimulation
Scores at the questionnaire on side effects of stimulation. Scores between 10 and 44 (higher scores mean worse outcome)
Measured: 1 time before (baseline) and within 1 hour after stimulation
Mood
Mood self-questionnaire. Scores between 0 and 100 (higher scores mean worse outcome)
Measured: 1 time before (baseline) and within 1 hour after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start16 Jan 2024
- Primary completion16 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine MONDINO, Phd, Principal investigator, hospital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936307
- Sponsor's protocol ID
- 2023-A00452-43
- Acronym
- STUPEFIX
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Auditory Externalization Abilities by Transcranial Stimulation of the Brain Area Specifically Involved
- ClinicalTrials.gov ID
- NCT05936307
- Acronym / sponsor ID
- STUPEFIX / 2023-A00452-43
- Conditions
- Healthy Participants
- Keywords
- externalization, auditory processing, reality-monitoring, stimulation, HD-TDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 15 healthy participants active then placebo | Active comparator | Procedure: High-definition transcranial direct current (HD-tDCS), active condition, Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition15 healthy participants will receive a session of active HD-tDCS and then a session of placebo HD-tDCS. |
| 15 healthy participants placebo then active | Placebo comparator | Procedure: High-definition transcranial direct current (HD-tDCS), active condition, Procedure: High-definition transcranial direct current (HD-tDCS), placebo condition15 healthy participants will receive a session of placebo HD-tDCS and then a session of active HD-tDCS. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having given their written informed consent
- Affiliated with a social security scheme
- French speakers and readers
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-definition transcranial direct current (HD-tDCS), active conditionParticipants 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 or surgery | 15 healthy participants active then placebo, 15 healthy participants placebo then active |
| High-definition transcranial direct current (HD-tDCS), placebo conditionParticipants 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 | Procedure or surgery | 15 healthy participants active then placebo, 15 healthy participants placebo then active |
Primary outcome
Externalization abilities
Time frame: one year
proportion of sounds perceived as coming from an external source in the externalization task (range 0-100%)
6 secondary outcomes
Reality monitoring performance
Time frame: one year
Self-agency
Time frame: one year
Psychometric characteristics that may influence externalization abilities and stimulation effects
Time frame: baseline
Psychometric characteristics that may influence externalization abilities and stimulation effects
Time frame: baseline
Side effects of stimulation
Time frame: 1 time before (baseline) and within 1 hour after stimulation
Mood
Time frame: 1 time before (baseline) and within 1 hour after stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marine MONDINO, Phd principal investigator
hospital le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition transcranial direct current (HD-tDCS), active condition in people with Healthy Participants, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine MONDINO, PhD (0437915565 ext. +33, marine.mondino@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Externalization abilities (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.