The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

NCT05925296 | Unknown

• 1 other identifier: 2022-SRFA-020
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blinded randomized study examining the effectiveness of the dual-site repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

Conditions

Parkinson Disease

Keywords

freezing of gait; rTMS

Outcome Measures

Primary Outcomes (1)

• Changes of Freezing of Gait Questionnaire

  The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome. The differences in FOG-Q scores before and after treatment can be used to evaluate the effect of TMS treatment.

  Assessed at baseline, one day post intervention, one month post intervention, six months post intervention

Secondary Outcomes (14)

• Changes of MDS-UPDRS

  Assessed at baseline, one day post intervention, one month post intervention, six months post intervention

• Gait speed

  Assessed at baseline, one day post intervention, one month post intervention, six month post intervention

• Stride length

  Assessed at baseline, one day post intervention, one month post intervention, six month post intervention

• Stride time variability

  Assessed at baseline, one day post intervention, one month post intervention, six month post intervention

• Double support

  Assessed at baseline, one day post intervention, one month post intervention, six month post intervention

Study Arms (3)

double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA

EXPERIMENTAL

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA.

Device: magnetic stimulation

single-site high frequency rTMS over the bilateral primary motor cortex of the lower leg

ACTIVE COMPARATOR

Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.

Device: magnetic stimulation

sham magnetic stimulation on motor cortex

SHAM COMPARATOR

Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1.

Device: magnetic stimulation

Interventions

magnetic stimulation DEVICE

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex.

double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA; sham magnetic stimulation on motor cortex; single-site high frequency rTMS over the bilateral primary motor cortex of the lower leg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
• Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
• Age between 40 and 80 years old.
• Mini-Mental State Examination score \>24.
• Ability to walk 30 meters independently.
• Stable medication.
• Patients experienced FOG during an interview.

You may not qualify if:

• Other neurological or psychiatric disorders.
• Severe personality disorder. History of epilepsy, seizures, or convulsions.
• History of head injury or stroke.
• Metal remains of the skull or inside the brain (outside the oral cavity).
• Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
• Severe dyskinesia, tremor, cognitive, visual or auditory impairment.
• Patients who could not complete the follow-up.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

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

Study Officials

• Kezhong Zhang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kezhong Zhang

CONTACT

13770840575; kezhong_zhang1969@126.com

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/Chief physician

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 29, 2023
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)