Clinical trial NCT05925296: The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
Official title: The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: freezing of gait
rTMS
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2023-06-29
Enrollment: 53
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 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.

Detailed description: 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. Assessments of FOG, gait function, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention, six 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 during an interview.

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

Primary outcomes:
measure: Changes of Freezing of Gait Questionnaire
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six months post intervention
Secondary outcomes:
measure: Changes of MDS-UPDRS
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six months post intervention
measure: Gait speed
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
measure: Stride length
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
measure: Stride time variability
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
measure: Double support
timeFrame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
measure: Resting motor threshold (RMT)
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
measure: Short-interval intracortical facilitation (SICF)
timeFrame: Assessed at baseline, one day post intervention
measure: Plasma indicators
timeFrame: Assessed at baseline, one day post intervention
measure: Changes in functional connectivity in the brain cortex
timeFrame: Assessed at baseline, one day post intervention, six month post intervention
measure: Changes in cerebral blood flow in the brain cortex
timeFrame: Assessed at baseline, one day post intervention, six month post intervention
measure: Brian structure compared among groups
timeFrame: Assessed at baseline, one day post intervention, six month 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: