Depression in Parkinson's Disease Clinical Trial
Official title:
The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Depression in Parkinson's Disease
Verified date | July 2019 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Patients diagnosed with Parkinson's Disease and depression will be recruited. All patients will be admitted and will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS for left dorsolateral prefrontal cortex (DLPFC) for 10 consecutive sessions totally over period of 10 days with repeated booster sessions every month during the period of follow up. The other will receive sham sessions.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 15, 2019 |
Est. primary completion date | March 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for depression (BDI > or = 14), and consent obtained from the patient or his caregiver. Exclusion Criteria: - History of repeated head injury - History of repeated cerebrovascular strokes - History of defined encephalitis - Oculogyric crisis, supranuclear gaze palsy - Family history of more than one relative - History of drug intake as antipsychotics or 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure - Moderate and Severe depression (Hamilton Depression Rating Scale score >16) - severe dysautonomia - Cerebellar signs - Babinski sign - Strictly unilateral features after 3 years - Hydrocephalus or intracranial lesion on neuroimaging - We also excludes patients with intracranial metallic devices or with pacemakers or any other device. - patients with cognitive impairment (Mini-Mental Status Examination< 24) |
Country | Name | City | State |
---|---|---|---|
Egypt | Assuit University | Assuit |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in depression severity measurements | Depression severity changes measured by Hamilton Depression Rating Scale (HAMD) | three months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Unknown status |
NCT01416818 -
Treatment of Depression in Parkinson's Disease
|
Phase 2 |