NCT03342846

Brief Summary

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study. The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

November 7, 2017

Last Update Submit

September 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in motor disability

    Measure the change in motor disability by using UPDRS and self assessment scale

    one month

Secondary Outcomes (1)

  • Changes in Cortical excitability

    Two weeks

Study Arms (2)

High Frequency rTMS in PD

ACTIVE COMPARATOR

The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.

Device: rTMS

Low Frequency rTMS in PD

ACTIVE COMPARATOR

The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.

Device: rTMS

Interventions

rTMSDEVICE

the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.

High Frequency rTMS in PDLow Frequency rTMS in PD

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All PD patients who were diagnosed according to UK bank criteria for PD.

You may not qualify if:

  • History of repeated head injury.
  • History of repeated cerebrovascular strokes
  • History of defined encephalitis
  • Oculogyric crisis, supra nuclear gaze palsy.
  • Family history of more than one relative
  • severe dementia, MMSE \< 23, severe depression
  • Cerebellar signs
  • Babiniski sign
  • Hydrocephalus or intracranial lesion on neuroimaging
  • Patients with intracranial on neuroimaging
  • Patients with intracranial metallic device or pacemaker
  • Patients who were unable to give informed consent because of severe anesthesia, or cognitive deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • eman M Khedr, MD

    Professor of Neurology, Faculty of Medicine, Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 17, 2017

Study Start

August 20, 2017

Primary Completion

February 25, 2018

Study Completion

February 25, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations