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Completed

NCT Number: NCT02717260

Inhibition Transcranial Random Noise Stimulation

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in go no go test

    Time frame: 15 minutes after the stimulation

    errors and reaction times

Secondary outcomes

  1. Change in Stroop test

    Time frame: 15 minutes after the stimulation

    errors and reaction times

  2. Change in Hayling test

    Time frame: 15 minutes after the stimulation

    errors and reaction times

  3. Change in BIS 10

    Time frame: 24 hours and 8 days after stimulations

    motor impulsivity, cognitive impulsivity, non planning impulsivity

  4. Change in STAXI

    Time frame: 24 hours and 8 days after stimulations

    score

  5. Change in STAI

    Time frame: 24 hours and 8 days after stimulations

    score

  6. Change in EEG

    Time frame: 24 hours and 8 days after stimulations

  7. occurrence of adverse effects

    Time frame: 8 days after stimulations

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: inhibistim

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2016
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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