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

Cairo University (CU)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: High Frequency Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05198076

P.T.REC/012/003448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

G1 ( Conventional Physical Therapy Program group)

No Intervention group

Description:

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.

G2 ( High Frequency rTMS group)

Experimental group

Description:

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.

Treatment:

Device: High Frequency Repetitive Transcranial Magnetic Stimulation