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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198076
• Other study ID #: P.T.REC/012/003448
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Engy BadrEldin S Moustafa, PhD
• Phone: 00201099445112
• Email: engybm.saleh[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 28, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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)

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Ad Doqi, Giza District, Giza Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.