The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Depression in Parkinson's Disease (PD)

Depression in Parkinson's Disease Clinical Trial

Official title:

The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Depression in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030923
• Other study ID #: rTMS and depression in PD
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Thirty PD patients with depression using United Kingdom (UK ) bank criteria for PD will be recruited from outpatient clinic in Assiut University. All patients will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each patient fulfilled the inclusion criteria as having score more than or equal 14 on Beck Depression Inventory (BDI) will be recruited. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for left DLPFC for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Depression
• Depression in Parkinson's Disease
• Depressive Disorder
• Parkinson Disease

Intervention

Device:
• repetitive transcranial magnetic stimulation
By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor Pollicis Brevis (APB), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for the left DLPFC (coil placed tangential over the optimal position of 7 cm anterior to hand motor hotspot area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.

Locations

Country	Name	City	State
Egypt	Assuit University	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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