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

Study Overview
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: High Frequency Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind Randomized Control Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: G1 ( Conventional Physical Therapy Program group)<br>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)<br>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<br>* 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)<br>* Other names: HF-rTMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall stability index (OSI) | 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) | 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) | 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 | 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 | 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. |