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

NCT04030923 | Completed

• 1 other identifier: rTMS and depression in PD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression in Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• changes in depression severity measurements

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

  three months

Study Arms (2)

Real rTMS

ACTIVE COMPARATOR

Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses on the left DLPFC for 10 consecutive sessions totally over period of 10 days.

Device: repetitive transcranial magnetic stimulation

sham rTMS

SHAM COMPARATOR

Sham rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses with coil perpendicular on scalp over the occipital cortex for 10 consecutive sessions totally over period of 10 days.

Device: repetitive transcranial magnetic stimulation

Interventions

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.

Real rTMS; sham rTMS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, 11517, Egypt

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eman Khedr, professor

  Neurology Department, Faculty of Medicine, Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asmaa mohamed mohamed mahmoud hasan assistant lecturer

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: July 24, 2019
• Study Start: July 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

EG (1)