Clinical trial NCT06415682: The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
Official title: The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
gait symptoms
freezing of gait
TMS
neural mechanism
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 64
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 efficacy of the double-site (M1+SMA) 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 double-site 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 single-site 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 group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, 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.

Eligibility criteria: Inclusion Criteria:

1. aged between 40-80 years;
2. diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
3. patients were stable on dopaminergic treatment for at least 3 months;
4. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
5. Patients experienced FOG during an interview.

Exclusion Criteria:

1. comorbidities of major neurologic diseases other than PD;
2. suffer from musculoskeletal disorders that could have interfered with their ability to walk;
3. presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
4. marked tremor interfered with TMS detection;
5. previously receiving any kinds of TMS interventions;
6. severe cognitive impairment making cooperation impossible \[Mini Mental State Examination (MMSE) \< 24\];
7. were unable to walk independently during the OFF state.

Primary outcomes:
measure: Changes of Freezing of Gait severity
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
Secondary outcomes:
measure: Freezing of Gait severity assessment
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Changes of Gait speed
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Changes of Stride length
timeFrame: Assessed at baseline, one day post intervention, one month post intervention
measure: Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)
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
measure: Changes in brain structure
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: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Kezhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: