Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease

NCT05456451 | Unknown

• 1 other identifier: 3616
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Upper Extremity Dysfunction; Tremor

Keywords

vagus nerve stimulation; tremor; parkinson disease; upper extremity

Outcome Measures

Primary Outcomes (2)

• tremor

  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. This application provides the opportunity to evaluate tremor numerically in patients with tremor, and there are studies where it has been used before in Parkinson's disease.

  1 day

• autonomic nervous system

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

  1 day

Study Arms (1)

Parkinson group(pre and post treatment)

EXPERIMENTAL

5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment

Device: noninvasive vagus nerve srimulation

Interventions

noninvasive vagus nerve srimulation DEVICE

Non-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease.

Parkinson group(pre and post treatment)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator
• Acibadem Atakent University Hospital: collaborator
• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: collaborator

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• E. Efe Is, M.D.

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ceyhun Basoglu, M.D.

  Acibadem Atakent University Hospital

  PRINCIPAL INVESTIGATOR

• Mustafa Corum, M.D.

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ali Veysel Ozden, M.D.

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Damla Korkmaz, M.D.

CONTACT

+90(212) 404 15 00; mervedml@gmail.com

A. Kivanc Menekseoglu, M.D.

CONTACT

+90(212) 404 15 00; kivancmenekseoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: July 25, 2022
• Primary Completion: September 25, 2022
• Study Completion: October 25, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)