The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

NCT06415682 | Completed

• 1 other identifier: 2024-SR-290
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; gait symptoms; freezing of gait; TMS; neural mechanism

Outcome Measures

Primary Outcomes (1)

• Changes of Freezing of Gait severity

  The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ 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

Secondary Outcomes (7)

• Freezing of Gait severity assessment

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

• Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)

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

• Changes of Gait speed

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

• Changes of Stride length

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

• Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)

  Assessed at baseline, one day 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: SMA+M1 Transcranial Magnetic Stimulation

single-site high frequency rTMS over the bilateral M1 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: M1 Transcranial Magnetic Stimulation

sham magnetic stimulation on the bilateral M1 of the lower leg

SHAM COMPARATOR

Patients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg.

Device: Sham Transcranial Magnetic Stimulation

Interventions

SMA+M1 Transcranial Magnetic Stimulation DEVICE

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration). Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).

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

M1 Transcranial Magnetic Stimulation DEVICE

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). 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.

single-site high frequency rTMS over the bilateral M1 of the lower leg

Sham Transcranial Magnetic Stimulation DEVICE

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

sham magnetic stimulation on the bilateral M1 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:

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

You may not qualify if:

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

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

Location

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

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: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 16, 2024
• Study Start: October 8, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)