Transcranial Magnetic Stimulation for Freezing of Gait in Parkinson's Disease

NCT07731841 | Completed

• 1 other identifier: 2021-SRFA-020-02
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Patients who did not achieve sufficient improvement after conventional TMS were further treated with a combined primary motor cortex and cerebellar stimulation protocol. The study aimed to identify factors associated with differential response to conventional TMS and to explore whether cerebellar stimulation could improve symptoms in treatment-resistant patients.

Conditions

Parkinson Disease (PD)

Outcome Measures

Primary Outcomes (1)

• Freezing of Gait Questionnaire Improvement Rate

  The improvement rate of the Freezing of Gait Questionnaire was calculated as \[(pre-treatment FOGQ score at baseline - post-treatment FOGQ score at one-month follow-up) / pre-treatment FOGQ score at baseline\] × 100%. Participants with an improvement rate of at least 30% were classified as treatment responsive.

  Baseline and 1 month after treatment

Secondary Outcomes (2)

• Unified Parkinson's Disease Rating Scale Part III Score

  Baseline, within 24 hours after treatment, and 1 month after treatment

• Upper-Limb Short-Interval Intracortical Inhibition

  Baseline and within 24 hours after treatment

Study Arms (4)

M1 Stimulation

EXPERIMENTAL

Participants received bilateral lower-limb primary motor cortex stimulation at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks.

Device: Primary Motor Cortex Transcranial Magnetic Stimulation

M1 Plus Spinal Cord Stimulation

EXPERIMENTAL

Participants received bilateral lower-limb primary motor cortex stimulation combined with transcutaneous spinal magnetic stimulation over the T10-T12 segment. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Spinal cord stimulation was delivered at 1 Hz with 1500 pulses. Treatment was administered once daily for five consecutive days per week over two weeks.

Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: Spinal Cord Magnetic Stimulation

M1 Plus SMA Stimulation

EXPERIMENTAL

Participants received bilateral lower-limb primary motor cortex stimulation combined with supplementary motor area stimulation. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered once daily for five consecutive days per week over two weeks.

Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: SMA TMS

M1 Plus Cerebellar Stimulation

EXPERIMENTAL

Treatment-resistant participants received bilateral lower-limb primary motor cortex stimulation combined with bilateral cerebellar intermittent theta-burst stimulation. Primary motor cortex stimulation parameters were unchanged. Cerebellar intermittent theta-burst stimulation was delivered bilaterally using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes.

Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: Cerebellar Intermittent Theta-Burst Stimulation

Interventions

Spinal Cord Magnetic Stimulation DEVICE

Transcutaneous spinal magnetic stimulation was delivered over the T10-T12 segment at 1 Hz, with 1500 pulses. Stimulation intensity was adjusted to produce visible lower-limb muscle contraction.

M1 Plus Spinal Cord Stimulation

SMA TMS DEVICE

Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered as an add-on protocol combined with bilateral lower-limb primary motor cortex stimulation.

M1 Plus SMA Stimulation

Cerebellar Intermittent Theta-Burst Stimulation DEVICE

Bilateral cerebellar intermittent theta-burst stimulation was delivered using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. This intervention was administered to patients who were treatment-resistant to conventional TMS.

M1 Plus Cerebellar Stimulation

Primary Motor Cortex Transcranial Magnetic Stimulation DEVICE

Bilateral lower-limb primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks.

M1 Plus Cerebellar Stimulation; M1 Plus SMA Stimulation; M1 Plus Spinal Cord Stimulation; M1 Stimulation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) a score of ≥ 1 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Item 13 or FOGQ Item 3, with freezing episodes during gait initiation, turning, or navigating narrow spaces confirmed by two independent investigators; (2) a stable antiparkinsonian medication regimen for at least four weeks before enrollment; (3) right-handedness; (4) age ≥ 40 years; (5) no current use of antidepressants, anxiolytics, or antipsychotic agents. Antiparkinsonian medications and their dosages remained unchanged throughout the study.

You may not qualify if:

• (1) personal or family history of atypical parkinsonian syndromes, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Wilson's disease, and vascular parkinsonism; (2) coexisting movement disorders or other neurodegenerative conditions; (3) gait-impairing disorders such as primary progressive freezing of gait; (4) impaired consciousness, or visual, auditory, or language deficits that precluded full assessment; (5) severe systemic diseases, including cardiopulmonary disorders, hepatic or renal insufficiency, malignancies, and hematologic or autoimmune diseases; (6) prior cranial surgery or deep brain stimulation (DBS); (7) pregnancy; (8) history of epilepsy; (9) severe cognitive impairment with a Mini-Mental State Examination (MMSE) score below 24; and (10) other contraindications to TMS.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: September 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: June 23, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)