The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD

NCT05174299 | Unknown

• 1 other identifier: 2021-SR-209
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.

Conditions

Parkinson Disease

Keywords

freezing of gait; Therapeutics; rTMS; spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Changes of Freezing of Gait Questionnaire (FOG-Q)

  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.

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

Secondary Outcomes (10)

• The motor part of the Unified Parkinson's Disease Rating Scale

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

• Gait speed

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

• Stride length

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

• Stride time variability

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

• Double support

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

Study Arms (3)

double active magnetic stimulation

EXPERIMENTAL

the multi-target magnetic stimulation on motor cortex combined with spinal cord

Device: magnetic stimulation

single active magnetic stimulation

ACTIVE COMPARATOR

the active magnetic stimulation on motor cortex and sham stimulation on spinal cord

Device: magnetic stimulation

double sham magnetic stimulation

SHAM COMPARATOR

the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord

Device: magnetic stimulation

Interventions

magnetic stimulation DEVICE

For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.

double active magnetic stimulation; double sham magnetic stimulation; single active magnetic stimulation

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 in both medication "on" and "off" states.

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, termor, cognitive, visual or auditory impairment.
• Patients who could not complete the follow-up.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

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

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 30, 2021
• Study Start: October 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)