Completed

NCT Number: NCT04030923

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

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.

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Key information

Conditions

Depression in Parkinson's Disease

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuit University

Asyut, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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.

Primary outcomes

changes in depression severity measurements

Time frame: three months

Depression severity changes measured by Hamilton Depression Rating Scale (HAMD)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 24, 2019
Registry last updated: Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.