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Inhibition Transcranial Random Noise Stimulation (inhibistim)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717260
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
HAESEBAERT, Hôpital le Vinatier

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.


Condition or disease Intervention/treatment Phase
Impulsive Behavior Inhibition Device: transcranial random noise stimulation (tRNS) (Starstim) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : September 29, 2016
Actual Study Completion Date : September 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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.




Primary Outcome Measures :
  1. Change in go no go test [ Time Frame: 15 minutes after the stimulation ]
    errors and reaction times


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717260


Locations
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France
Ch Le Vinatier
Lyon, Rhone Alpes, France, 69678
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: HAESEBAERT Frederic, MD PhD HOPITAL VINATIER
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Responsible Party: HAESEBAERT, MD PhD, Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02717260    
Other Study ID Numbers: 2015-A01554-45
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Impulsive Behavior