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

Primary Purpose

Advanced Parkinson's With Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
repetitive transcranial magnetic (rTMS)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Parkinson's With Dysphagia

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eman Khedr

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS

Sham rTMS

Arm Description

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

Each patient received rTMS with the same pulse as the first group but with the coil placed perpendicular to the scalp.

Outcomes

Primary Outcome Measures

changes in dysphagia severity measurement
Dysphagia severity changes measured by Dysphagia Handicap Index (DHI)

Secondary Outcome Measures

swallowing changes pre and post 10 sessions using
Measurement of swallowing changes pre and post 10 sessions using video fluoroscopy (VFS).

Full Information

First Posted
October 7, 2017
Last Updated
September 12, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03317509
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Parkinson's With Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Each patient received rTMS with the same pulse as the first group but with the coil placed perpendicular to the scalp.
Intervention Type
Procedure
Intervention Name(s)
repetitive transcranial magnetic (rTMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in dysphagia severity measurement
Description
Dysphagia severity changes measured by Dysphagia Handicap Index (DHI)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
swallowing changes pre and post 10 sessions using
Description
Measurement of swallowing changes pre and post 10 sessions using video fluoroscopy (VFS).
Time Frame
ten days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Khedr
Organizational Affiliation
Professor of Neurology, Faculty of Medicine, Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman Khedr
City
Assiut
State/Province
Assiut, Egypt
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

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

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