Non-invasive brain stimulation and wearable vibration device for treatment of frozen gait in Parkinson's disease and its mechanism

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076291

Enrollment

Unknown

Registered

2023-09-28

Start date

2023-07-20

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Frozen of gait group:Wearable vibration device

Non-Frozen of gait group:Wearable vibration device

Frozen of gait group:Transcranial magnetic stimulation

Frozen of gait group:Wearable vibration device and transcranial magnetic stimulation

Non-Frozen of gait group:None

Health control group:None

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of patients with Parkinson's disease meets the diagnostic criteria of 2015-MDS Parkinson's disease; 2. H/Y grade 2-4 patients; 3. Stable drug use; 4. MMSE score is greater than or equal to 24 points, visual and auditory normal, can cooperate to complete the test; 5. Confirm the FOG by UPDRS-II-13. FOG can be induced by standardized gait tasks (including gait initiation, narrow channel, dual task and bidirectional rapid 360° axial rotation). 6. Subjects voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Cerebral hemorrhage, cerebral infarction, poisoning, trauma and other definite lesions that can lead to Parkinson's symptoms; 2. Patients with lumbar spine, double leg, knee joint surgery and previous trauma or skin defect; 3. Patients with implantable pacemakers, deep brain stimulators and other metal in the body; 4. Can not cooperate with the experimental operator. 5. Comorbidities (stroke, visual impairment, hearing loss, peripheral nerve disease, dementia, mental illness, etc.)

Design outcomes

Primary

Measure	Time frame
Short intracortical inhibition;Long intracortical inhibition;Short-latency afferent inhibition;Long-latency afferent inhibition;New Freezing of Gait Questionnaire;Timed Up& Go;	—

Secondary

Measure	Time frame
Minimum Mental State Examination;Hoehn-Yahr;Tinetti Balance and Gait Analysis;HAMA, HAMD;Berg Balance Scale;	—

Countries

China

Contacts

Public ContactXianwen Chen

First Affiliated Hospital of Anhui Medical University

chxwmail@aliyun.com+86 139 5693 9016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026