Clinical trial NCT02717260: Inhibition Transcranial Random Noise Stimulation
Official title: Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impulsive Behavior
Inhibition
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inhibition control deficits is a major risk factor in the transition to the act in suicidal patients. Neuroimaging studies have shown that this failure was associated with hypoactivity in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was recently shown that a noninvasive brain stimulation session applied on the PFC reduces transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the activity and connectivity of neural network connected to the stimulation site. The investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC will allow a more intense and longer lasting effect on impulsivity and cognitive control in healthy volunteers compared to a single session and to placebo stimulation. The investigators assume that this behavioral change will be accompanied by a change in brain activity measured by resting EEG for the patients in the active group. A more intense and longer lasting effect is an essential step to transfer these results to patient populations.

The main objective is to study the effect of bilateral stimulation of the PFC by transcranial random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS on verbal inhibition (measured with the Hayling test); on anxiety (measured with the State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the neuronal electrical activity measured by EEG.

Detailed description: Subjects are stimulated 3 times in a day. Each 20 minutes stimulation are separated by a period of at least 30 minutes. Before and after each stimulation, inhibition is evaluated by cognitive tests (Go Nogo test, Stroop test, Hayling test) and by the BIS 10 scale. During the stimulation, subjects compleat the STAXI and STAI scales. Cognitive tests are repeated 24 hours and 8 days after the stimulation to evaluate duration of the effect. Possible side effects will be notified throughout the protocol.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 45 years

Exclusion Criteria:

* inability to give consent
* Under 18 years
* over 45 years
* pregnant women
* nursing mothers
* History of neurological or psychiatric disorders and personality disorders in Cluster impulsivity (cluster B) according to Diagnostic and Statistical Manual (DSM) IV
* french National Adult Reading Test (fNART): score below the 5th percentile
* Contraindications to the practice of transcranial brain stimulation as international safety recommendations (Rossi et al., 2009)
* Processing or recent psychotropic

Primary outcomes:
measure: Change in go no go test
timeFrame: 15 minutes after the stimulation
Secondary outcomes:
measure: Change in Stroop test
timeFrame: 15 minutes after the stimulation
measure: Change in Hayling test
timeFrame: 15 minutes after the stimulation
measure: Change in BIS 10
timeFrame: 24 hours and 8 days after stimulations
measure: Change in STAXI
timeFrame: 24 hours and 8 days after stimulations
measure: Change in STAI
timeFrame: 24 hours and 8 days after stimulations
measure: Change in EEG
timeFrame: 24 hours and 8 days after stimulations
measure: occurrence of adverse effects
timeFrame: 8 days after stimulations
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ch Le Vinatier
state: Rhone Alpes
Study officials:
affiliation: HOPITAL VINATIER
name: HAESEBAERT Frederic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: