Inhibition Transcranial Random Noise Stimulation (inhibistim)

Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test

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.

Study Overview

• Status: Completed
• Conditions: Impulsive Behavior; Inhibition
• Intervention / Treatment: Device: transcranial random noise stimulation (tRNS) (Starstim)

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69678
      • CH Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Sham transcranial noise stimulation; subjects are stimulated 3 times with sham transcranial random noise stimulation (tRNS) (Starstim) with a 30 seconds offset	Device: transcranial random noise stimulation (tRNS) (Starstim); subjects are stimulated 3 times in a day by transcranial random noise stimulation (tRNS) (Starstim). 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.
ACTIVE_COMPARATOR: 1 Active transcranial random noise stimulation; subjects are stimulated 1 time with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes and 2 times with sham tRNS	Device: transcranial random noise stimulation (tRNS) (Starstim); subjects are stimulated 3 times in a day by transcranial random noise stimulation (tRNS) (Starstim). 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.
ACTIVE_COMPARATOR: 3 Active transcranial random noise stimulation; subjects are stimulated 3 times with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes	Device: transcranial random noise stimulation (tRNS) (Starstim); subjects are stimulated 3 times in a day by transcranial random noise stimulation (tRNS) (Starstim). 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in go no go test	errors and reaction times	15 minutes after the stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stroop test	errors and reaction times	15 minutes after the stimulation
Change in Hayling test	errors and reaction times	15 minutes after the stimulation
Change in BIS 10	motor impulsivity, cognitive impulsivity, non planning impulsivity	24 hours and 8 days after stimulations
Change in STAXI	score	24 hours and 8 days after stimulations
Change in STAI	score	24 hours and 8 days after stimulations
Change in EEG		24 hours and 8 days after stimulations
occurrence of adverse effects		8 days after stimulations

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: HAESEBAERT Frederic, MD PhD, Hopital Vinatier

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2016
• Primary Completion (ACTUAL): September 29, 2016
• Study Completion (ACTUAL): September 29, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Impulsive Behavior
• Other Study ID Numbers: 2015-A01554-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO