Parkinson's disease.
Conditions
Interventions
Intervention 1: Control group: Placebo, intranasal administration, every day, twice a day, in both sides, for 12 weeks. Intervention 2: Intervention group: Insulin, intranasal administration, 40 IU/da
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Inclusion criteria
Inclusion criteria: Man and woman over 17 years old Patient with Parkinson's disease according to UKPDSBB criteria Provide written informed consent to participate in the study Understand that they may withdraw their consent at any time.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Patients with diabetes and taking anti-hyperglycemic drugs 3. Other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc. 4. Patients who cannot walk for more than one minute without help. 5. Patients with history of allergic reactions to insulin 6. Patients with history of nasal cavity inflammation that prevents insulin absorption 7. Patients with kidney and liver diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of motor symptoms. Timepoint: Motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part III, IV). | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of non-motor symptoms. Timepoint: Non-motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part I, II).;Score of depression. Timepoint: Depression score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Beck's Depression Inventory II questionnaire.;Score of anxiety. Timepoint: Anxiety score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Beck Anxiety Inventory (BAI) questionnaire.;Score of fatigue severity. Timepoint: fatigue score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Fatigue Severity Scale (FSS) questionnaire.;Score of disease severity. Timepoint: severity score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Modified Hoehn and Yahr (HY) questionnaire.;Score of cognitive symptoms. Timepoint: Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Montreal Cognitive Assessment (MOCA) questionnaire.;Score of cognitive symptoms. Timepoint: Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Scales for Outcomes of Parkinson’s disease-cognition (SCOPA-COG) questionnaire.;Score of Falling. Timepoint: Falling score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention. Method of measurement: Tinetti Balance Assessment Tool questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehri Salari
Shahid Beheshti University of Medical Sciences
Outcome results
None listed