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High Versus Low Frequency rTMS on Motor Dysfunction in PD

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ClinicalTrials.gov Identifier: NCT03342846
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Eman M. Khedr, 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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of High Versus Low Frequency Repetitive Transcranial Magnetic Stimulation on Motor Dysfunction in Parkinson's Disease; Which is More Beneficial?
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High Frequency rTMS in PD
The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Device: 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.

Active Comparator: Low Frequency rTMS in PD
The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.
Device: 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.




Primary Outcome Measures :
  1. change in motor disability [ Time Frame: one month ]
    Measure the change in motor disability by using UPDRS and self assessment scale


Secondary Outcome Measures :
  1. Changes in Cortical excitability [ Time Frame: Two weeks ]
    Measure the changes in cortical excitability using magnetic stimulation appratus



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342846


Locations
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Egypt
Eman Khedr
Assiut, Egypt, 11517
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: eman M Khedr, MD Professor of Neurology, Faculty of Medicine, Assiut University

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Responsible Party: Eman M. Khedr, Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03342846     History of Changes
Other Study ID Numbers: High versus low TMS in PD.
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases