Parkinson Disease
Conditions
Keywords
Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms
Brief summary
This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.
Detailed description
This study is a single-center, parallel and double-blind study. Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.
Interventions
DRUGInsulin
20 IU twice a day, intranasally, every day for 12 weeks
DRUGNormal saline
twice a day, intranasally, every day for 12 weeks
Sponsors
dr.dargahi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man and woman over 17 years old * Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria * Provide written informed consent to participate in the study. * Understand that they may withdraw their consent at any time.
Exclusion criteria
* Pregnant and lactating women * Patients with diabetes and taking anti-hyperglycemic drugs * Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc. * Patients who cannot walk for more than one minute without help * A history of allergic reaction to insulin * The presence of inflammation of nasal cavity that may prevents absorption of insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV | Base line, 4, 8 and 12 weeks after intervention | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease severity | Base line, 4, 8 and 12 weeks after intervention | The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson's Disease. The scale ranges from 1 to 5. The lower score indicates better outcome. |
| Risk of Falling | Base line, 4, 8 and 12 weeks after intervention | Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling. |
| Cognitive score | Base line, 4, 8 and 12 weeks after intervention | The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance. |
| Depression score | Base line, 4, 8 and 12 weeks after intervention | Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression. |
| Anxiety score | Base line, 4, 8 and 12 weeks after intervention | Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety. |
| Fatigue score | Base line, 4, 8 and 12 weeks after intervention | Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue. |
| Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II | Base line, 4, 8 and 12 weeks after intervention | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II assess the non motor signs of PD; higher score means more severity of the symptoms. |
Countries
Iran
Outcome results
None listed