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

NCT ID: NCT03317509

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-16
• Study Completion Date: 2018-02-20

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.

Conditions

Advanced Parkinson's With Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real 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

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic (rTMS)

Intervention Type: PROCEDURE

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.

Sham rTMS

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

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic (rTMS)

Intervention Type: PROCEDURE

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.

Interventions

repetitive transcranial magnetic (rTMS)

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman M. Khedr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman M Khedr

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology, Faculty of Medicine, Assiut University

Locations

Eman Khedr

Asyut, Assiut, Egypt, Egypt

Countries

Egypt

Other Identifiers

TMS on Parkinson dysphagia

Identifier Type: -

Identifier Source: org_study_id