High Versus Low Frequency rTMS on Motor Dysfunction in PD

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: rTMS

• Registration Number: NCT03342846
• Lead Sponsor: Assiut University

Brief Summary

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

Detailed Description

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week and 2 days off per week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

Study Timeline

• Study Start: 2017-08-20
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Primary Completion: 2018-02-25
• Study Completion: 2018-02-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All PD patients who were diagnosed according to UK bank criteria for PD.

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Exclusion Criteria

• History of repeated head injury.
• History of repeated cerebrovascular strokes
• History of defined encephalitis
• Oculogyric crisis, supra nuclear gaze palsy.
• Family history of more than one relative
• severe dementia, MMSE < 23, severe depression
• Cerebellar signs
• Babiniski sign
• Hydrocephalus or intracranial lesion on neuroimaging
• Patients with intracranial on neuroimaging
• Patients with intracranial metallic device or pacemaker
• Patients who were unable to give informed consent because of severe anesthesia, or cognitive deficit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency rTMS in PD	rTMS	The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Low Frequency rTMS in PD	rTMS	The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.

Primary Outcome Measures

Name	Time	Method
change in motor disability	one month	Measure the change in motor disability by using UPDRS and self assessment scale

Secondary Outcome Measures

Name	Time	Method
Changes in Cortical excitability	Two weeks	Measure the changes in cortical excitability using magnetic stimulation appratus

Trial Locations

Locations (1)

Eman Khedr; 🇪🇬 Assiut, Egypt