Back to resultsHigh Versus Low Frequency rTMS on Motor Dysfunction in PD
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Eman Khedr
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High Frequency rTMS in PD
Low Frequency rTMS in PD
Arm Description
The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.
The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Outcomes
Primary Outcome Measures
change in motor disability
Measure the change in motor disability by using UPDRS and self assessment scale
Secondary Outcome Measures
Changes in Cortical excitability
Measure the changes in cortical excitability using magnetic stimulation appratus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03342846
Brief Title
High Versus Low Frequency rTMS on Motor Dysfunction in PD
Official Title
The Effect of High Versus Low Frequency Repetitive Transcranial Magnetic Stimulation on Motor Dysfunction in Parkinson's Disease; Which is More Beneficial?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
February 25, 2018 (Actual)
Study Completion Date
February 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Frequency rTMS in PD
Arm Type
Active Comparator
Arm Description
The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Arm Title
Low Frequency rTMS in PD
Arm Type
Active Comparator
Arm Description
The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.
Primary Outcome Measure Information:
Title
change in motor disability
Description
Measure the change in motor disability by using UPDRS and self assessment scale
Time Frame
one month
Secondary Outcome Measure Information:
Title
Changes in Cortical excitability
Description
Measure the changes in cortical excitability using magnetic stimulation appratus
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eman M Khedr, MD
Organizational Affiliation
Professor of Neurology, Faculty of Medicine, Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman Khedr
City
Assiut
ZIP/Postal Code
11517
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
High Versus Low Frequency rTMS on Motor Dysfunction in PD
We'll reach out to this number within 24 hrs