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tDCS, Stress and Risk for Schizophrenia (3S)

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ClinicalTrials.gov Identifier: NCT03217357
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Device: Transcranial stimulation in direct current Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The subject will be blind of the treatment he receives (active or placebo).

- The experimenter will also be blinded from stimulation (active or placebo) Each subject will be assigned a randomization code, corresponding to the code to enter the tDCS device. This system allows the person who administers tDCS and the subject receiving the stimulation to be blind .

Primary Purpose: Basic Science
Official Title: Effects of Transcranial Direct Current Stimulation on Stress Reactivity and Decision Making in Unaffected Siblings of Patients With Schizophrenia
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Transcranial stimulation in direct current(tDCS)active
30 minutes of active Transcranial stimulation in direct current
Device: Transcranial stimulation in direct current
tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo

Placebo Comparator: Transcranial stimulation in direct current(tDCS) placebo
30 minutes of placebo stimulation
Device: Transcranial stimulation in direct current
tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo




Primary Outcome Measures :
  1. Cortisol [ Time Frame: One year ]
    Salivary cortisol will be analyzed, using Salivette tubes


Secondary Outcome Measures :
  1. Decision-making capacities [ Time Frame: 6 mois ]
    Decision-making capacities will be measured using a computerized version of the delay discounting task in which participants have to choose between 2 rewards

  2. electroencephalography [ Time Frame: 6 mois ]
    EEG will be acquired twice. It consists in an at rest recording of EEG 64 channels, eyes closed to measure spectral power intensities



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject to genetic risk of schizophrenia, related first-degree schizophrenic patient
  • Man and woman
  • Age between 18 and 30 years old

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217357


Contacts
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Contact: D AMATO THIERRY, MD - PhD 00334 37 91 51 36 thierry.damato@ch-le-vinatier.fr
Contact: BRUNELIN JEROME, PhD 00334 37 91 55 65 jerome.brunelin@ch-le-vinatier.fr

Locations
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France
Centre Hospitalier Le Vinatier Recruiting
Bron Cedex, France, 69678
Contact: Thierry D'AMATO, PH    04 37 91 51 00    thierry.damato@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: D AMATO THIERRY, MD - PhD CH LE VINATIER

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT03217357     History of Changes
Other Study ID Numbers: 2017-A00850-53
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
tDCS, non invasive brain stimulation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders