Parkinson Disease (PD)
Conditions
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.
Interventions
DEVICEPrimary Motor Cortex Transcranial Magnetic Stimulation
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.
DEVICESpinal Cord Magnetic Stimulation
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.
DEVICESMA TMS
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.
DEVICECerebellar Intermittent Theta-Burst Stimulation
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of Gait Questionnaire Improvement Rate | Baseline and 1 month after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale Part III Score | Baseline, within 24 hours after treatment, and 1 month after treatment | Motor symptoms were assessed using the Unified Parkinson's Disease Rating Scale Part III. |
| Upper-Limb Short-Interval Intracortical Inhibition | Baseline and within 24 hours after treatment | Upper-limb short-interval intracortical inhibition was assessed using paired-pulse transcranial magnetic stimulation and expressed as the conditioned/unconditioned motor evoked potential amplitude ratio. |
Countries
China
Outcome results
None listed