Inhibition Transcranial Random Noise Stimulation

Impulsive Behavior Clinical Trial

— inhibistim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717260
• Other study ID #: 2015-A01554-45
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: May 9, 2017
• Start date: February 2, 2016
• Est. completion date: September 29, 2016

Study information

• Verified date: May 2017
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 29, 2016
• Est. primary completion date: September 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Impulsive Behavior
• Inhibition

Intervention

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.

Locations

Country	Name	City	State
France	Ch Le Vinatier	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in go no go test	errors and reaction times	15 minutes after the stimulation
Secondary	Change in Stroop test	errors and reaction times	15 minutes after the stimulation
Secondary	Change in Hayling test	errors and reaction times	15 minutes after the stimulation
Secondary	Change in BIS 10	motor impulsivity, cognitive impulsivity, non planning impulsivity	24 hours and 8 days after stimulations
Secondary	Change in STAXI	score	24 hours and 8 days after stimulations
Secondary	Change in STAI	score	24 hours and 8 days after stimulations
Secondary	Change in EEG		24 hours and 8 days after stimulations
Secondary	occurrence of adverse effects		8 days after stimulations