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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02717260
Other study ID # 2015-A01554-45
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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