Clinical trial NCT05174299: The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD
Official title: The Effect of Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: freezing of gait
Therapeutics
rTMS
spinal cord stimulation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients in the Experimental group 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, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low 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 and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.

Eligibility criteria: Inclusion Criteria:

* 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
* 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
* 3.Age between 40 and 80 years old.
* 4.Mini-Mental State Examination score \>24.
* 5.Ability to walk 30 meters independently.
* 6.Stable medication.
* 7.Patients experienced FOG in both medication "on" and "off" states.

Exclusion Criteria:

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

Primary outcomes:
measure: Changes of Freezing of Gait Questionnaire (FOG-Q)
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
Secondary outcomes:
measure: The motor part of the Unified Parkinson's Disease Rating Scale
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Gait speed
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Stride length
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Stride time variability
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Double support
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Resting motor threshold (RMT)
timeFrame: Assessed at baseline, one day post intervention.
measure: MEP amplitude at 120% RMT intensity (AMP)
timeFrame: Assessed at baseline, one day post intervention.
measure: Cortical silent period (CSP)
timeFrame: Assessed at baseline, one day post intervention.
measure: Short-interval intracortical inhibition (SICI)
timeFrame: Assessed at baseline, one day post intervention.
measure: Intracortical facilitation (ICF)
timeFrame: Assessed at baseline, one day post intervention.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiang Su
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Kezhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: