Inhibition Transcranial Random Noise Stimulation

NCT02717260 | Completed DMC

• 1 other identifier: 2015-A01554-45
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsive Behavior; Inhibition

Outcome Measures

Primary Outcomes (1)

• Change in go no go test

  errors and reaction times

  15 minutes after the stimulation

Secondary Outcomes (7)

• Change in Stroop test

  15 minutes after the stimulation

• Change in Hayling test

  15 minutes after the stimulation

• Change in BIS 10

  24 hours and 8 days after stimulations

• Change in STAXI

  24 hours and 8 days after stimulations

• Change in STAI

  24 hours and 8 days after stimulations

Study Arms (3)

Sham transcranial noise stimulation

SHAM COMPARATOR

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)

1 Active transcranial random noise stimulation

ACTIVE COMPARATOR

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)

3 Active transcranial random noise stimulation

ACTIVE COMPARATOR

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)

Interventions

transcranial random noise stimulation (tRNS) (Starstim) DEVICE

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.

1 Active transcranial random noise stimulation; 3 Active transcranial random noise stimulation; Sham transcranial noise stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Impulsive Behavior; Inhibition, Psychological

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• HAESEBAERT Frederic, MD PhD

  HOPITAL VINATIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: March 23, 2016
• Study Start: February 2, 2016
• Primary Completion: September 29, 2016
• Study Completion: September 29, 2016
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)