The Effect of High Frequency rTMS on Advancing Parkinson's Disease With Dysphagia

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the therapeutic role of rTMS on parkinson's patients with dysphagia. Thirty PD patients with dysphagia using UK bank criteria for PD will recruited from outpatient clinic in Assuit University. All patients were admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt. Each patient fulfilled the inclusion criteria as spontaneous swallows should be identified clearly when patients cannot perform voluntary swallows using clinical examination test. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.

Detailed Description
-----------------
This study aims to assess the therapeutic role of repetitive transcranial magnetic (rTMS) on parkinson's patients with dysphagia. Thirty PD patients with dysphagia using UK bank criteria for PD will recruited from outpatient clinic in Assuit University. All patients were admitted at, Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt. Each patient fulfilled the inclusion criteria as spontaneous swallows should be identified clearly when patients cannot perform voluntary swallows using clinical examination test. The patients will be allocated randomly into two groups using closed envelops one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. the other will receive sham sessions. All subjects after receiving the rTMS will be followed up by selected clinical rating scales at different intervals Pre session, post 10 sessions, after one, two and three months.

Official Title
-----------------
The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Advancing Parkinson's Disease With Dysphagia

Conditions
-----------------
Advanced Parkinson's With Dysphagia

Intervention / Treatment
-----------------
* Procedure: repetitive transcranial magnetic (rTMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All parkinson's disease patients who were diagnosed according to UK bank criteria for PD, Aged 50-75 years, with dysphagia Exclusion Criteria: History of repeated head injury History of repeated cerebrovascular strokes History of defined encephalitis Oculogyric crisis, supranuclear gaze palsy Family history of more than one relative History of drug intake as antipsychotics or MPTP exposure Severe dementia, (MMSE < 23), Severe depression (H- D) < severe dysautonomia Cerebellar signs Babiniski sign Strictly unilateral features after 3 years Hydrocephalus or intracranial lesion on neuroimaging We also excluded patients with intracranial metallic devices or with pacemakers or any other device. Patients who were unable to give informed Consent because of severe anesthesia or cognitive deficit were not included.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS<br>Each patient received high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days | Procedure: repetitive transcranial magnetic (rTMS)<br>* Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days. Sham rTMS is the same pulse as the first group but with the coil placed perpendicular to the scalp.<br>|
| Sham Comparator: Sham rTMS<br>Each patient received rTMS with the same pulse as the first group but with the coil placed perpendicular to the scalp. | Procedure: repetitive transcranial magnetic (rTMS)<br>* Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days. Sham rTMS is the same pulse as the first group but with the coil placed perpendicular to the scalp.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in dysphagia severity measurement | Dysphagia severity changes measured by Dysphagia Handicap Index (DHI) | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| swallowing changes pre and post 10 sessions using | Measurement of swallowing changes pre and post 10 sessions using video fluoroscopy (VFS). | ten days |