Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05263414 |
Other study ID # |
847 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2022 |
Est. completion date |
April 30, 2023 |
Study information
Verified date |
February 2022 |
Source |
IRCCS Eugenio Medea |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The investigators planned a single centre, randomized, double-blind, sham- controlled,
crossover (within subject) design.
Adults with Tic Disorders will be recruited and randomly assigned to two different groups:
the active-tVNS group and the sham-tVNS group. Each group will undergo a two-sessions
intervention during which active tVNS followed by sham tVNS or sham tVNS followed by active
tVNS will be delivered in the active and sham tVNS group, respectively. The stimulation will
be delivered during the execution of an inhibitory task and an attentional task. For the
inhibitory task a Contextual Go No-Go paradigm will be used. During this task, participants
will be presented with visual stimuli representing everyday actions embedded within congruent
or incongruent context. For example, stimuli could consist in precision or grasping actions
suggesting the intention to eat or to move the object in another place. For each stimulus,
there will be a kinematic component consisting in the movement performed by the model and a
contextual component, consisting in the embedding scenario of the action (a breakfast
scenario, or a cleaning scenario). Participants will be instructed to press a button when a
specific intention (go) will be suggested by the video and not to press a button for the
opposite intention (no go), either according to the kinematics or to the context, depending
on the experimental block. This way, it will be possible to assess inhibitory control at
response level. Crucially, kinematics and context of the visual stimuli could point toward
the same (congruent) or opposite (incongruent) intentions, thus allowing to assess inhibitory
control at the stimulus level. For the attentional task, the attentional network test (ANT;
Fan et al.,2002) will be used. The task is a modified version of a Flanker task and it allows
measuring orienting, alerting and executive control components. To assess the clinical,
neuropsychological and behavioural profiles, the Yale Global Tic Severity Rating Scale
(YGTSS), the EuroQol quality of life questionnaire, the Raven Matrix, the Autism Quotient,
the Barratt Impulsiveness scale and the Navon Task will be used. The effects of tVNS on
patients' behavioural control (as assessed through the Contextual Go No-Go task and the ANT)
will be related to clinical, neuropsychological and behavioural profile, for identifying best
the features tVNS responder patients. Side effects will be tested after each session.
The protocol will allow testing the efficiency of tVNS in:
- enhancing inhibition at response level (response selection) in Tic disorders;
- enhancing inhibition at stimulus level (response inhibition) in Tic disorders;
- improving alerting, orienting or executive control in Tic disorders;
- improving patients' quality of life and Tic control;
- further investigating the safety and tolerability of tVNS.