High Versus Low Frequency rTMS on Motor Dysfunction in PD

NCT ID: NCT03342846

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2018-02-25

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High Frequency rTMS in PD

The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.

Low Frequency rTMS in PD

The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.

Interventions

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rTMS

the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Eman M. Khedr

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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eman M Khedr, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology, Faculty of Medicine, Assiut University

Locations

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Eman Khedr

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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High versus low TMS in PD.

Identifier Type: -

Identifier Source: org_study_id

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