Clinical trial NCT05198076: 6 Month Follow up Study on the Changes of Postural Stability in Parkinsonian Patients in Response to High Frequency TMS.
Official title: The Long Term Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation on Postural Stability in Parkinsonian Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 40
Sex: MALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind Randomized Control Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall stability index (OSI)
timeFrame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
measure: Antero-posterior Stability index (APSI)
timeFrame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
measure: Medio-lateral stability index (MLSI)
timeFrame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
measure: Directional control percent
timeFrame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
measure: Time to complete test
timeFrame: Changes from Pre-intervention to immediately post intervention, Changes from immediately post intervention to six month follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Ad Doqi, Giza District, Giza Governorate
Study officials:
affiliation: Cairo University
name: Engy BadrEldin S Moustafa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.