High Versus Low Frequency rTMS on Motor Dysfunction in PD
The Effect of High Versus Low Frequency Repetitive Transcranial Magnetic Stimulation on Motor Dysfunction in Parkinson's Disease; Which is More Beneficial?
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Aug 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2017
CompletedFirst Submitted
Initial submission to the registry
November 7, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2018
CompletedSeptember 16, 2020
September 1, 2020
6 months
November 7, 2017
September 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in motor disability
Measure the change in motor disability by using UPDRS and self assessment scale
one month
Secondary Outcomes (1)
Changes in Cortical excitability
Two weeks
Study Arms (2)
High Frequency rTMS in PD
ACTIVE COMPARATORThe first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Low Frequency rTMS in PD
ACTIVE COMPARATORThe second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Interventions
the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.
Eligibility Criteria
You may qualify if:
- All PD patients who were diagnosed according to UK bank criteria for PD.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eman Khedr
Asyut, 11517, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
eman M Khedr, MD
Professor of Neurology, Faculty of Medicine, Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2017
First Posted
November 17, 2017
Study Start
August 20, 2017
Primary Completion
February 25, 2018
Study Completion
February 25, 2018
Last Updated
September 16, 2020
Record last verified: 2020-09