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NCT Number: NCT05198076

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

55 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High frequency repetitive transcranial magnetic stimulation

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)

Other names: HF-rTMS

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Engy BadrEldin S Moustafa, PhD

CONTACT

[email protected]

00201099445112

Engy BadrEldin S Moustafa, PhD

CONTACT

[email protected]

+971506501530

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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