Idiopathic Parkinson's disease Nervous System Diseases Parkinson's Disease
Conditions
Interventions
Patients will be allocated randomly to one of two intervention arms, - active nVNS or sham nVNS, such that both patient and experimenter will be blinded to the intervention. After the baseline assessm
(2) 6–8 hours after the first treatment
and (3) 6–8 hours after the second treatment.
The devices were dispensed in a randomised and blinded manner. Simple randomisation was performed using a computer-generated list of random numbers to as
Sponsors
Institute of Neurosciences Kolkata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with PD and FOG 2. Age ranging from 30-80 years 3. Can walk independently at a stretch for at least 30 meters without support 4. PD patients were diagnosed as per UKPDS (full form) Brain Bank Criteria
Exclusion criteria
Exclusion criteria: 1. Significant visual impairment 2. Coexisting local or systemic diseases (e.g. osteoarthritis, other neurological conditions) which is likely to affect walking 3. History of Deep Brain Stimulation surgery or cardiac pacemakers were also excluded to ensure safe use of nVNS 4. Metallic implant/ metal cervical spine hardware near the stimulation site 5. Known or suspected cardiovascular disease, uncontrolled hypertension, recent myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and 1 month 1. Two dimensional spatio-temporal gait parameters derived from GAITRite walkway 2. Motor function using UPDRS III scrore 3. Extent of freezing of gait estimated from post hoc video analysis and FOGQ score | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and 1 month 1. Cognitive parameters assessed by MMSE, Mattis DRS scores 2. Severity of REM sleep behavior disorder from REM sleep behavior disorder screening questionnaire RBDSQ 3. Fear of fall by Fall Efficacy Scale 4. Peripheral biomarkers from serum sample (TNF- Alpha, IL-6, IL 10, reduced glutathione, superoxide dismutase) | — |
Countries
India
Contacts
Public ContactHrishikesh Kumar
Outcome results
None listed