Neuromodulation of Inhibitory Control in Tic Disorders

NCT05263414 | Unknown

• 1 other identifier: 847
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to assess the effects of non invasive electrical stimulation of the vagus nerve via transcutaneous vagus nerve stimulation (tVNS) on cognitive functions, inhibitory and tic control in patients with tic disorders. Taking into account the role that GABA plays in inhibitory control, the presence of alteration of GABA neurotransmission in Tic disorders and the possibility to increase GABA release with tVNS, the investigators hypothesized that tVNS might improve behavioral control in Tic disorders. Moreover, as suggested by previous studies investigating the effects of tVNS in other patient populations, the investigators expected that tVNS will be safe and well tolerated. Such results would encourage the use of tVNS in Tic disorders.

Conditions

Tic Disorders

Keywords

Transcutaneous vagus nerve stimulation; Tic disorders; Tourette syndrome; Inhibition; Tic control

Outcome Measures

Primary Outcomes (2)

• Contextual Go No-Go

  Performance in the contextual go no go task, consisting in the accuracy in making the response in the presence of a go stimulus, and not responding in the presence of a no-go stimulus (Response selection) as a function of different level of congruency between the kinematics and the contextual cues (stimulus selection). Change in inhibition at response level (response selection) and at stimulus level (response inhibition) after active tVNS.

  Time 1- at the end the active session vs Time 0- at the end of the sham session

• Attentional Network Test

  Performance in the ANT tasks, with respect to the three components: alerting, orienting, executive control. For the alerting component, the mean RT of the correct trials in the double-cues conditions will be subtracted from the mean RT of the no-cue condition. For the Orienting component, the effect will be calculated by subtracting the mean RT of the spatial cue condition from the mean RT of the central cue condition. For the executive control component, the effect will be obtained by subtracting the mean RT of the incongruent flanking condition from the mean RT of the congruent flanking condition.Change in alerting, orienting, executive control after active tVNS.

  Time 1- at the end the active session vs Time 0- at the end of the sham session

Secondary Outcomes (3)

• Tic control

  Time 1- at the end the active tVNS session vs Time 0- at the end of the sham session

• tVNS feasibility

  Time 1- at the end the active tVNS session vs Time 0- at the end of the sham session

• tVNS acceptability

  Time 1- at the end the active tVNS session

Study Arms (2)

Active tVNS

ACTIVE COMPARATOR

In the active tVNS session, tVNS will be delivered via a programmable stimulation unit connected to two titan ear electrodes mounted on a gel frame. Active tVNS will be delivered over the cymba conchae of the left ear for a 70 minutes session. Stimulation intensity will be set at an intensity corresponding to individual sensitivity threshold. The intensity of the stimulation will be gradually increased in order to reach the intensity of stimulation with a ramping-up phase of 30 secs. During the stimulation, participants will perform the tasks. At the end of the stimulation session participants will be asked to report possible side effects occurring during tVNS and to rate their feeling on several visual analogue scales.

Device: tVNS

Sham tVNS

SHAM COMPARATOR

In the sham tVNS session tVNS will be delivered via a programmable stimulation unit connected to two titan ear electrodes mounted on a gel frame. Sham tVNS will be delivered over the left lobe auricle area, which is free from cutaneous vagal innervation. It will last 70 minutes. Stimulation intensity will be set at the intensity corresponding to the individual sensitivity threshold, as it will be defined on the left ear lobe. The intensity of the stimulation will be gradually increased to reach the intensity of the stimulation with a ramping up phase of 30 secs. During the sham stimulation, the tasks will be performed. At the end of the stimulation session participants will be asked to report possible side effects occurring during tVNS and to rate their feeling on several visual analogue scales.

Device: tVNS

Interventions

tVNS DEVICE

tVNS allows the non-invasive activation of the Vagus Nerve by delivering electrical pulses to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. TVNS seems to engage the same neural pathways of invasive VNS methods and may provide a novel, bottom-up NIBS method to promote GABA release. tVNS will be performed by using a CE marked tVNS device. It consists in a programmable stimulation unit connected to two titan ear electrodes that are mounted on a gel frame, allowing to generate and transfer electric impulses from the stimulation unit to the surface of the skin, where the electrodes are applied.

Active tVNS; Sham tVNS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults who aged 18-50 years;
• Diagnosis of Tic disorders

You may not qualify if:

• Presence of contraindication to tVNS (history of epilepsy in the last two years, severe brain trauma; presence of metal in the brain/skull or implanted neurostimulator, cardiac pacemaker; state of pregnancy);
• Recent changes in drugs therapy due to the intake of or the withdrawal from some drugs potentially changing the seizure threshold;
• Presence of comorbidity with an important medical condition;
• Severe sensorial, motor and/or behavioural problems that could interfere with the tasks

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute, IRCCS E. Medea,

Pasian di Prato, Udine, 33037, Italy

Location

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Before data analyses, for ten years.
• Access Criteria: all

Locations

IT (1)