6 Month Follow up Study on the Changes of Postural Stability in Parkinsonian Patients in Response to High Frequency TMS.

November 16, 2025 updated by: Engy Badreldin Saleh Moustafa, PhD, Cairo University

The Long Term Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation on Postural Stability in Parkinsonian Patients.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Ad Doqi, Giza District, Giza Governorate
      • Giza, Ad Doqi, Giza District, Giza Governorate, Egypt, 11432
        • Recruiting
        • Faculty of physical therapy, Cairo University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Device: 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 Names:
  • HF-rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall stability index (OSI)
Time Frame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Biodex Balance System SD (Model 945-302, software version 3.12, New York). The system consists of a circular platform supported. It can tilt 20° in all directions from the horizontal. The system's microprocessor-based actuator controls the extent of the surface instability of the platform. The system will evaluate two components of balance (balance indices and dynamic limit of stability). To assess balance indices; each patient was asked to maintain the center of mass in the middle of a concentric circle that appeared on the screen placed in front of the patient. The instrument records the actual postural sway and calculates the variance from the center, which is expressed as a balance index.
Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Antero-posterior Stability index (APSI)
Time Frame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Biodex Balance System SD (Model 945-302, software version 3.12, New York). The system consists of a circular platform supported. It can tilt 20° in all directions from the horizontal. The system's microprocessor-based actuator controls the extent of the surface instability of the platform. The system will evaluate two components of balance (balance indices and dynamic limit of stability). To assess balance indices; each patient was asked to maintain the center of mass in the middle of a concentric circle that appeared on the screen placed in front of the patient. The instrument records the actual postural sway and calculates the variance from the center, which is expressed as a balance index.
Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Medio-lateral stability index (MLSI)
Time Frame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Biodex Balance System SD (Model 945-302, software version 3.12, New York). The system consists of a circular platform supported. It can tilt 20° in all directions from the horizontal. The system's microprocessor-based actuator controls the extent of the surface instability of the platform. The system will evaluate two components of balance (balance indices and dynamic limit of stability). To assess balance indices; each patient was asked to maintain the center of mass in the middle of a concentric circle that appeared on the screen placed in front of the patient. The instrument records the actual postural sway and calculates the variance from the center, which is expressed as a balance index.
Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Directional control percent
Time Frame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
To assess dynamic limit of stability; each patient will be asked to move the center of mass, without changing foot position, into 8 targets (in forward, backward, right ,left, forward-right, forward-left, backward-right, and backward-left direction), the perimeter of which corresponded to 50 percent of the theoretical LOS. The target is displayed on the screen by a blinking square, which appeared randomly in different directions only once. The instrument will calculate the shortest vertical or horizontal path to reach the target from the center in each direction which will be expressed as the directional control score.
Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Time to complete test
Time Frame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Each patient will be asked to move the center of mass, without changing foot position, into 8 targets (in forward, backward, right ,left, forward-right, forward-left, backward-right, and backward-left direction), Then the instrument will calculate the time taken to complete each test, the maximum time allowed to perform the movements to complete the LOS test was 300 seconds.
Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Engy BadrEldin S Moustafa, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

December 18, 2025

Study Completion (Estimated)

February 18, 2026

Study Registration Dates

First Submitted

January 2, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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