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

Not Applicable

Completed

• Conditions: Advanced Parkinson's With Dysphagia
• Interventions: Procedure: repetitive transcranial magnetic (rTMS)

• Registration Number: NCT03317509
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2017-07-16
• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Primary Completion: 2018-02-20
• Study Completion: 2018-02-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All parkinson's disease patients who were diagnosed according to UK bank criteria for PD, Aged 50-75 years, with dysphagia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	repetitive transcranial magnetic (rTMS)	Each patient received rTMS with the same pulse as the first group but with the coil placed perpendicular to the scalp.
Real rTMS	repetitive transcranial magnetic (rTMS)	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

Primary Outcome Measures

Name	Time	Method
changes in dysphagia severity measurement	Three months	Dysphagia severity changes measured by Dysphagia Handicap Index (DHI)

Secondary Outcome Measures

Name	Time	Method
swallowing changes pre and post 10 sessions using	ten days	Measurement of swallowing changes pre and post 10 sessions using video fluoroscopy (VFS).

Trial Locations

Locations (1)

Eman Khedr; 🇪🇬 Assiut, Assiut, Egypt, Egypt