6 Month Follow up Study on the Changes of Postural Stability in Parkinsonian Patients in Response to High Frequency TMS.
NCT ID: NCT05198076
Last Updated: 2025-11-19
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-23
2026-02-18
Brief Summary
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Detailed Description
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Biodex balance system will be used to assess objectively balance indices (overall, anterio-posterior and medio-lateral balance index) and dynamic limit of stability (overall LOS score, time to complete test) pretreatment , posttreatment and one month later as a follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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G1 ( Conventional Physical Therapy Program group)
Patients in (G1) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises. The treatment will be conducted three sessions per week, day after day for successive four weeks. The session duration was 40min to 1 hour.
No interventions assigned to this group
G2 ( High Frequency rTMS group)
Patients in (G2) will be treated by high frequency repetitive transcranial magnetic stimulation (HF-rTMS) in addition to the same physiotherapy program as in G1. The treatment will be conducted three sessions per week, day after day for successive four weeks. The session duration for rTMS will be 20-30 minutes, the physiotherapy session will be 40-45 min.
High Frequency Repetitive Transcranial Magnetic Stimulation
The High Frequency repetitive TMS will be delivered to the scalp over the primary motor cortex contralateral to the more affected side using a MAGSTIM rapid2 machine (Model P/N 3576-23-09, MAGSTIM Company LTD, UK) connected with a figure - of- eight shaped coil. Each patient will receive 12 sessions over four weeks. Position of the coil will be adjusted to find the optimal scalp position and the location of stimulation that will be marked to maintain consistency among sessions. The session will consist of 24 trains of 50 stimuli each delivered at five Hz. The procedure will be conducted with the patients in the ''On'' state (75 min. after medications)
Interventions
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High Frequency Repetitive Transcranial Magnetic Stimulation
The High Frequency repetitive TMS will be delivered to the scalp over the primary motor cortex contralateral to the more affected side using a MAGSTIM rapid2 machine (Model P/N 3576-23-09, MAGSTIM Company LTD, UK) connected with a figure - of- eight shaped coil. Each patient will receive 12 sessions over four weeks. Position of the coil will be adjusted to find the optimal scalp position and the location of stimulation that will be marked to maintain consistency among sessions. The session will consist of 24 trains of 50 stimuli each delivered at five Hz. The procedure will be conducted with the patients in the ''On'' state (75 min. after medications)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with mild to moderate disease severity according to UPRS and Modified Hoehn and Yahr staging
* Duration of illness from two to five years were included.
* All included patients should be medically and psychologically stable and of adequate cardiac function.
* All included patients should haven't receive any rTMS sessions before.
* Signed consent form should be taken from all included patients.
Exclusion Criteria
* Patients with severe freezing phenomenon or severe tremors were excluded
55 Years
70 Years
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Engy Badreldin Saleh Moustafa, PhD
Lecturer of P.T for neuromuscular disorders and its surgery
Principal Investigators
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Engy BadrEldin S Moustafa, PhD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of Physical Therapy, Cairo University
Giza, Ad Doqi, Giza District, Giza Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Kim SD, Allen NE, Canning CG, Fung VS. Postural instability in patients with Parkinson's disease. Epidemiology, pathophysiology and management. CNS Drugs. 2013 Feb;27(2):97-112. doi: 10.1007/s40263-012-0012-3.
Benninger DH, Iseki K, Kranick S, Luckenbaugh DA, Houdayer E, Hallett M. Controlled study of 50-Hz repetitive transcranial magnetic stimulation for the treatment of Parkinson disease. Neurorehabil Neural Repair. 2012 Nov-Dec;26(9):1096-105. doi: 10.1177/1545968312445636. Epub 2012 May 15.
Maruo T, Hosomi K, Shimokawa T, Kishima H, Oshino S, Morris S, Kageyama Y, Yokoe M, Yoshimine T, Saitoh Y. High-frequency repetitive transcranial magnetic stimulation over the primary foot motor area in Parkinson's disease. Brain Stimul. 2013 Nov;6(6):884-91. doi: 10.1016/j.brs.2013.05.002. Epub 2013 May 29.
Brandmeir NJ, Brandmeir CL, Kuzma K, McInerney J. A Prospective Evaluation of an Outpatient Assessment of Postural Instability to Predict Risk of Falls in Patients with Parkinson's Disease Presenting for Deep Brain Stimulation. Mov Disord Clin Pract. 2015 Nov 27;3(2):151-155. doi: 10.1002/mdc3.12257. eCollection 2016 Mar-Apr.
Yang YR, Tseng CY, Chiou SY, Liao KK, Cheng SJ, Lai KL, Wang RY. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair. 2013 Jan;27(1):79-86. doi: 10.1177/1545968312451915. Epub 2012 Jul 10.
Ganesan M, Sathyaprabha TN, Gupta A, Pal PK. Effect of partial weight-supported treadmill gait training on balance in patients with Parkinson disease. PM R. 2014 Jan;6(1):22-33. doi: 10.1016/j.pmrj.2013.08.604. Epub 2013 Sep 8.
Vadala M, Vallelunga A, Palmieri L, Palmieri B, Morales-Medina JC, Iannitti T. Mechanisms and therapeutic applications of electromagnetic therapy in Parkinson's disease. Behav Brain Funct. 2015 Sep 7;11:26. doi: 10.1186/s12993-015-0070-z.
Other Identifiers
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P.T.REC/012/003448
Identifier Type: -
Identifier Source: org_study_id
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