Parkinson Disease Clinical Trial
Official title:
Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease
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.
Status | Not yet recruiting |
Enrollment | 5 |
Est. completion date | October 25, 2022 |
Est. primary completion date | September 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Kucukcekmece |
Lead Sponsor | Collaborator |
---|---|
Kanuni Sultan Suleyman Training and Research Hospital | Acibadem Atakent University Hospital, Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |