Study Results
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Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2019-05-02
2023-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
\- 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 .
Study Groups
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Transcranial stimulation in direct current(tDCS)active
30 minutes of active Transcranial stimulation in direct current
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
Transcranial stimulation in direct current(tDCS) placebo
30 minutes of placebo stimulation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Man and woman
* Age between 18 and 30 years old
Exclusion Criteria
* Psychiatric disorder on axis I of DSM 5
* Pregnant or nursing women
18 Years
30 Years
ALL
No
Sponsors
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Hôpital le Vinatier
OTHER
Responsible Party
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Principal Investigators
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D AMATO THIERRY, MD - PhD
Role: PRINCIPAL_INVESTIGATOR
CH LE VINATIER
Locations
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Centre Hospitalier Le Vinatier
Bron, , France
Countries
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Other Identifiers
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2017-A00850-53
Identifier Type: -
Identifier Source: org_study_id
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