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NCT07731841

Overview

NCT ID: NCT07731841
Lead Sponsor: The First Affiliated Hospital with Nanjing Medical UniversityOTHER
Official Title: Mechanisms of Differential Response to Transcranial Magnetic Stimulation in Freezing of Gait in Parkinson's Disease and Cerebellar Stimulation Intervention for Treatment-Resistant Patients
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)

Status and Timeline

Status: Completed
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 1, 2021Actual
Primary Completion Date: Dec 30, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 85Actual
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: The First Affiliated Hospital with Nanjing Medical University

Similar Studies

Participant Group/Arms

M1 StimulationExperimental

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 StimulationExperimental

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

M1 Plus SMA StimulationExperimental

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

M1 Plus Cerebellar StimulationExperimental

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