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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-02-18

Brief Summary

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Postural instability is one of the cardinal signs in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease. It is associated with frequent falls and loss of independence. The aim of the current study is to assess the long term efficacy of high frequency repetitive transcranial magnetic stimulation (rTMS) on improving postural instability in PD patients.

Detailed Description

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Thirty to forty PD patients will be recruited who fulfill the U.K Parkinson's Disease Brain Bank Criteria for idiopathic PD. Patients with mild to moderate disease severity according to UPRS and Modified Hoehn and Yahr staging, age ranged from 55-70 years, duration of illness from two to five years will be included. The patients who will match our inclusion criteria will be assigned randomly into two equal groups; control group (G1) will receive a designed physical therapy program and study group (G2) will receive 12 sessions of (5Hz) rTMS over the primary motor cortex in addition to the same physical therapy program as in G1. The treatment will be conducted three times per week, over four weeks.

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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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Randomized Control Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Randomization was done using Sealed envelopes

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

High Frequency Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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)

Intervention Type DEVICE

Other Intervention Names

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HF-rTMS

Eligibility Criteria

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Inclusion Criteria

* All included patients should fulfill the U.K Parkinson's Disease Brain Bank Criteria for idiopathic PD.
* 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 implanted devices, serious medical illness or history of seizures were excluded.
* Patients with severe freezing phenomenon or severe tremors were excluded
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Engy Badreldin Saleh Moustafa, PhD

Lecturer of P.T for neuromuscular disorders and its surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Engy BadrEldin S Moustafa, PhD

Role: CONTACT

00201099445112

Engy BadrEldin S Moustafa, PhD

Role: CONTACT

+971506501530

Facility Contacts

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Engy BadrEldin S Moustafa, PhD

Role: primary

00201099445112

Moshera H. Darwish, PhD

Role: backup

00201015163617

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.

Reference Type BACKGROUND
PMID: 23076544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22593114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23769414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30713907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22785003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24021298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26347217 (View on PubMed)

Other Identifiers

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P.T.REC/012/003448

Identifier Type: -

Identifier Source: org_study_id

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