rTMS for the Treatment of Freezing of Gait in Parkinson's Disease

NCT03219892 | Completed Results DMC

• 1 other identifier: Z171100000117013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The investigators hypothesize that treatment with rTMS on supplemental motor area will improve gait quality and decrease the frequency of FOG in PD patients.

Conditions

Parkinson's Disease

Keywords

freezing of gait; rTMS; fMRI

Outcome Measures

Primary Outcomes (1)

• Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score

  NFOGQ ranges from 0-24 points. It is used to quantify changes of the FOG frequency and severity. Higher scores mean a worse outcome.

  Pre-treatment, post-treatment 4 weeks

Secondary Outcomes (4)

• Motor Subscale of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)

  Pre-treatment, post-treatment 4 weeks

• Cadence

  Pre-treatment, post-treatment 4 weeks

• Turning Duration

  Pre-treatment, post-treatment 4 weeks

• Changes of Brain Functional Connectivity.

  Pre-treatment, post-treatment at 2 weeks

Study Arms (2)

High-frequency rTMS

EXPERIMENTAL

Patients randomized to this group will receive rTMS delivering over the supplementary motor area (SMA). Each treatment consists 1000 pulses (5-second burst of 10Hz rTMS, repeated 20 times at every minute ).Stimulus intensity is 90% of resting motor threshold. A figure-of-8 coil is connected to a biphasic magnetic stimulator, and the induced current is perpendicular to the midline.

Device: High-frequency rTMS

Sham rTMS

SHAM COMPARATOR

Patients randomized to this group will receive the sham rTMS. The procedure is same as used in patients receiving experimental rTMS, except that the coil is angled 90° away.

Device: Sham rTMS

Interventions

High-frequency rTMS DEVICE

It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline.

High-frequency rTMS

Sham rTMS DEVICE

The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away.

Sham rTMS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic PD patients.
• Presenting with FOG.
• The mini-mental state examination questionnaire score above 24 points.

You may not qualify if:

• Other neurological or psychiatric disorders.
• History of epilepsy, seizures or convulsions.
• Metal implantation.
• History of exposure to rTMS in the past (to minimizing risk of unblinding sham condition).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, 100053, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Piu Chan
• Organization: Xuanwu Hospital

pbchan@hotmail.com

010-83198677

Study Officials

• Piu Chan, MD, PhD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 18, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)