MedPath

The Effect of Local Injection of Botulinum Toxin in Parkinson's Patients

Phase 4
Recruiting
Conditions
Parkinson's Disease.
Parkinson's disease
Registration Number
IRCT20100127003217N11
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
35
Inclusion Criteria

Patients with idiopathic or familial Parkinson's disease (Parkinson's disease or PD); age between 30 to 85 years, one year after definitive diagnosis; patients with PD who have hand tremor (single-sided or bilateral).
Patients with PD who are in stages I-III of Hoehn & Yahr staging .
Patients with PD who are being treated with routine anti-Parkinson drugs, especially levodopa.
Patients with PD who are willing to participate in the study and are satisfied with botulinum toxin injections.

Exclusion Criteria

Patients with PD who have had cognitive impairment or psychosis
Patients with PD who have had a history of botulinum Toxin injection or any other injection over the past four months
Patients with PD who have had a history of surgery (DBS: deep brain stimulation)
Patients with secondary Parkinsonism, such as Pharmaceutical Parkinsonism
Patients with hand tremor which is resulting from a medical condition, such as antipsychotic drugs
Pregnancy and breastfeeding

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical severity of hand tremor. Timepoint: At the beginning of the study and before the intervention, 1.5 months, 4 months after injection. Method of measurement: 2 questionnaires including FTM (Fahn_Tolosa_Marin Temor Rating Scale) and UPDRS (Unified Parkinsone Disease Rating Scale).
Secondary Outcome Measures
NameTimeMethod
Functional severity of hand tremor. Timepoint: At the beginning of the study and before the intervention, 1.5 months, 4 months after injection. Method of measurement: ADL questionnaire from Bain and Findley questionnaire, manual dynamometer, 10 euro coin test.
© Copyright 2025. All Rights Reserved by MedPath