NCT05198076

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-07-23
• Primary completion: 2025-12-18
• Completion: 2026-02-18
• First posted: 2022-01-20
• Last updated: 2025-11-19

Locations

1 site across 1 country: Egypt