Clinical trial NCT03317509: The Effect of High Frequency rTMS on Advancing Parkinson's Disease With Dysphagia
Official title: The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Advancing Parkinson's Disease With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Parkinson's With Dysphagia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: changes in dysphagia severity measurement
timeFrame: Three months
Secondary outcomes:
measure: swallowing changes pre and post 10 sessions using
timeFrame: ten days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Eman Khedr
state: Assiut, Egypt
Study officials:
affiliation: Professor of Neurology, Faculty of Medicine, Assiut University
name: Eman M Khedr
role: PRINCIPAL_INVESTIGATOR
References: