Schizophrenia3SNCT03217357
tDCS, Stress and Risk for Schizophrenia
A study testing Transcranial stimulation in direct current in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Transcranial stimulation in direct current
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 31 Jul 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subject to genetic risk of schizophrenia, related first-degree schizophrenic patient
- Man and woman
- Age between 18 and 30 years old
Who cannot join
- Contraindications to the practice of the tDCS, for safety measure, we will use the same contraindications as the practice of the Magnetic resonance imaging
- Psychiatric disorder on axis I of DSM 5
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Stress Reactivity and Decision Making in Unaffected Siblings of Patients With Schizophrenia
An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected siblings of patients) displayed an intermediate hyperreactivity to stress as compared with patients and healthy controls.
Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol can modulate decision making processes and modulate biological reactivity to stress by decreasing salivary cortisol concentration in acute stress condition.
Read the detailed description
The objective of this project is to evaluate how the modulation of DLPFC activity in acute stress condition influences decision-making in unaffected siblings of patients with schizophrenia.
Methods: 30 unaffected siblings of patients with schizophrenia will be enrolled and randomized into 2 groups. 15 subjects will receive active tDCS (2mA, 30 min, anode left DLPFC, cathode right DLPFC) and 15 will receive sham tDCS.
tDCS procedure: There is a total of 30 minutes of stimulation at the intensity of 2mA (ramp up and ramp down: 30 sec). Sham stimulation consists in delivering 1 minute of real stimulation. The stimulation site (DLPFC) will be anatomically determined according to 10/20 EEG system (F3 \& F4). This procedure is in accordance with international guidelines for safety. Safety and blinding will be assessed using specific tools at the end of the protocol.
Stress paradigm: In order to induce moderate stress in humans in laboratory condition, the investigators will use the Maastricht Acute Stress Test (MAST). This test is a combination between physical (hand immersion in cold water) and cognitive (arithmetic calculation) stress. Test will start 5 minutes after the beginning of stimulation session.
Decision-making paradigm: The decision-making task will be performed before and after the MAST (during the stimulation) in order to compare changes induce by stress and/or stimulation. The choose test is the Delay Discounting Task (DDT) permitting a measure of decision-making, reward seeking and impulsivity.
Stress measure: Saliva samples will be collected using a Salivette®, samples will be stored frozen (- 20°C). Saliva cortisol levels will be measured by ELISA. The investigators also will measure heart rate, systolic and diastolic blood pressures at each time of saliva extraction (each 15 minutes, 1st sample at 9:00 am, please see figure 1). Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) before and after stimulation
- Conditions
- Schizophrenia
- Being tested
- Transcranial stimulation in direct current
- Keywords
- tDCS, non invasive brain stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulation in direct currentDevice
tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo
| Study group | Role | What they receive |
|---|---|---|
| Transcranial stimulation in direct current(tDCS)active | Active comparator | 30 minutes of active Transcranial stimulation in direct current Receives: Device: Transcranial stimulation in direct current |
| Transcranial stimulation in direct current(tDCS) placebo | Placebo comparator | 30 minutes of placebo stimulation Receives: Device: Transcranial stimulation in direct current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
Salivary cortisol will be analyzed, using Salivette tubes
Measured: One year
Secondary outcomes (2)
Decision-making capacities
Decision-making capacities will be measured using a computerized version of the delay discounting task in which participants have to choose between 2 rewards
Measured: 6 mois
electroencephalography
EEG will be acquired twice. It consists in an at rest recording of EEG 64 channels, eyes closed to measure spectral power intensities
Measured: 6 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start2 May 2019
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- In a randomized controlled double blind study, 30 subjects, first-degree relatives of schizophrenic patients, were randomly assigned to 2 groups. A group of 15 participants will receive 30 minutes of active tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC); A group of 15 participants will receive 30 minutes of placebo stimulation. During this stimulation session, all participants will undergo a standardized stress test combining psychosocial stress and physical stress
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D AMATO THIERRY, MD - PhD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217357
- Sponsor's protocol ID
- 2017-A00850-53
- Acronym
- 3S
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2017
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Stress Reactivity and Decision Making in Unaffected Siblings of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03217357
- Acronym / sponsor ID
- 3S / 2017-A00850-53
- Conditions
- Schizophrenia
- Keywords
- tDCS, non invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 14 Jul 2017 (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.
An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected siblings of patients) displayed an intermediate hyperreactivity to stress as compared with patients and healthy controls.
Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol can modulate decision making processes and modulate biological reactivity to stress by decreasing salivary cortisol concentration in acute stress condition.
Detailed description
The objective of this project is to evaluate how the modulation of DLPFC activity in acute stress condition influences decision-making in unaffected siblings of patients with schizophrenia.
Methods: 30 unaffected siblings of patients with schizophrenia will be enrolled and randomized into 2 groups. 15 subjects will receive active tDCS (2mA, 30 min, anode left DLPFC, cathode right DLPFC) and 15 will receive sham tDCS.
tDCS procedure: There is a total of 30 minutes of stimulation at the intensity of 2mA (ramp up and ramp down: 30 sec). Sham stimulation consists in delivering 1 minute of real stimulation. The stimulation site (DLPFC) will be anatomically determined according to 10/20 EEG system (F3 \& F4). This procedure is in accordance with international guidelines for safety. Safety and blinding will be assessed using specific tools at the end of the protocol.
Stress paradigm: In order to induce moderate stress in humans in laboratory condition, the investigators will use the Maastricht Acute Stress Test (MAST). This test is a combination between physical (hand immersion in cold water) and cognitive (arithmetic calculation) stress. Test will start 5 minutes after the beginning of stimulation session.
Decision-making paradigm: The decision-making task will be performed before and after the MAST (during the stimulation) in order to compare changes induce by stress and/or stimulation. The choose test is the Delay Discounting Task (DDT) permitting a measure of decision-making, reward seeking and impulsivity.
Stress measure: Saliva samples will be collected using a Salivette®, samples will be stored frozen (- 20°C). Saliva cortisol levels will be measured by ELISA. The investigators also will measure heart rate, systolic and diastolic blood pressures at each time of saliva extraction (each 15 minutes, 1st sample at 9:00 am, please see figure 1). Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) before and after stimulation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a randomized controlled double blind study, 30 subjects, first-degree relatives of schizophrenic patients, were randomly assigned to 2 groups. A group of 15 participants will receive 30 minutes of active tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC); A group of 15 participants will receive 30 minutes of placebo stimulation. During this stimulation session, all participants will undergo a standardized stress test combining psychosocial stress and physical stress
| Arm | Type | Receives |
|---|---|---|
| Transcranial stimulation in direct current(tDCS)active | Active comparator | Device: Transcranial stimulation in direct current30 minutes of active Transcranial stimulation in direct current |
| Transcranial stimulation in direct current(tDCS) placebo | Placebo comparator | Device: Transcranial stimulation in direct current30 minutes of placebo stimulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject to genetic risk of schizophrenia, related first-degree schizophrenic patient
- Man and woman
- Age between 18 and 30 years old
Key exclusion criteria (3 listed)
- Contraindications to the practice of the tDCS, for safety measure, we will use the same contraindications as the practice of the Magnetic resonance imaging
- Psychiatric disorder on axis I of DSM 5
- Pregnant or nursing women
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 |
|---|---|---|
| Transcranial stimulation in direct currenttDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo | Device | Transcranial stimulation in direct current(tDCS) placebo, Transcranial stimulation in direct current(tDCS)active |
Primary outcome
Cortisol
Time frame: One year
Salivary cortisol will be analyzed, using Salivette tubes
2 secondary outcomes
Decision-making capacities
Time frame: 6 mois
electroencephalography
Time frame: 6 mois
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
D AMATO THIERRY, MD - PhD principal investigator
CH 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 Transcranial stimulation in direct current in people with Schizophrenia, 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 3 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: finished, as of the sponsor's last update on 23 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (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 23 Feb 2024.