Clinical trial NCT05456451: Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Official title: Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Upper Extremity Dysfunction
Tremor
Keywords: vagus nerve stimulation
tremor
parkinson disease
upper extremity
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Sisli Hamidiye Etfal Training and Research Hospital
name: Acibadem Atakent University Hospital
name: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
First posted: 2022-07-13
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.
Primary purpose: TREATMENT

Brief summary: Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.

In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.

The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.

Detailed description: Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.

5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.

The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.

The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.

The participants will be evaluated pre and post-treatment.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 40-65.
* Diagnosed with Parkinson's Disease by a specialist neurologist.
* Hoehn-Yahr stage 2-3.
* Having bilateral resting tremor of the hands.
* Being agreed to participate in the study.

Exclusion Criteria:

* Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
* Severe depression (Beck Depression Scale \> 29)
* Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
* Pregnancy or planning to become pregnant or breast-feed during the study period.
* Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.

Primary outcomes:
measure: tremor
timeFrame: 1 day
measure: autonomic nervous system
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: E. Efe Is, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Acibadem Atakent University Hospital
name: Ceyhun Basoglu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
name: Mustafa Corum, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University
name: Ali Veysel Ozden, M.D.
role: PRINCIPAL_INVESTIGATOR
References: