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Neuro-behavioral mechanisms of personalized non-invasive subthalamic nucleus stimulation in modulating the cortex-basal ganglia-thalamus circuit

Neuro-behavioral mechanisms of personalized non-invasive subthalamic nucleus stimulation in modulating the cortex-basal ganglia-thalamus circuit

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127286
Enrollment
Unknown
Registered
2026-06-29
Start date
2025-07-18
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Motor Control/PD

Interventions

Healthy Adults:A crossover design is employed. Participants are randomized to receive a single session of "TI Stimulation - Washout - Sham" or "Sham - Washout - TI Stimulation". TI parameters: carrier
Parkinson's Disease Patients:This group includes two phases: Short-term phase: Participants receive single sessions of TI stimulation and Sham stimulation in a randomized crossover sequence. TI parame
Sham involves no envelope frequency. Total duration is 21 minutes per session (including 30s ramp-up/down). Long-term phase: Following the crossover phase, participants receive 4 weeks of active TI st

Sponsors

Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Healthy Adults Right-handed No history of neurological or psychiatric disorders No movement disorders No metallic implants 2. Parkinson's Disease Patients (1) Diagnosis of idiopathic Parkinson's disease confirmed according to the UK Brain Bank criteria (2) Age 40 years or older (3) Hoehn and Yahr (H&Y) scale stage 1.5–3 (4) Good general health status with no personal or family history of psychiatric or neurological disorders (5) Ability to walk unassisted for at least 5 minutes, both under freezing of gait (FOG) and non-FOG conditions (6) Currently receiving stable pharmacological treatment

Exclusion criteria

Exclusion criteria: 1. Healthy Adults Pregnancy History of epilepsy History of intracranial surgery Current use of medications known to affect the central nervous system 2. Parkinson's Disease Patients (1) Any psychiatric or cognitive impairment (Montreal Cognitive Assessment [MoCA] score < 24) (2) Receipt of any non-invasive brain stimulation within the preceding week (3) Any contraindication to electrical stimulation, including: metallic implants in the body, prior brain surgery, inability to tolerate electrical current, allergy to conductive gel, or personal or family history of epilepsy (4) Presence of any condition other than Parkinson's disease that may affect gait or balance (5) Current participation in another research study (6) Inability to maintain adequate mental alertness throughout the experimental procedure (7) Inability to comprehend or follow experimental task instructions (8) Engagement in strenuous physical activity within 24 hours prior to the experiment (9) Participation in any gait training program within the one month preceding enrollment (10) Physician-diagnosed cardiovascular risk factors contraindicating physical exertion

Design outcomes

Primary

MeasureTime frame
Resting-state Functional Magnetic Resonance Imaging (rs-fMRI); Diffusion Tensor Imaging (DTI);Go/No-go Reaction Time (RT);Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III);New Freezing of Gait Questionnaire (NFOG-Q);High-Density Electromyography (HD-EMG) Signal;

Secondary

MeasureTime frame
Task-based functional Magnetic Resonance Imaging;Neurometabolite concentrations;Biomechanical Measures (Motion Capture System): 10-Meter Walking Test;Muscle Strength;Montreal Cognitive Assessment (MoCA);Adverse Events Questionnaire;

Countries

China

Contacts

Public ContactZhiqiang Zhu

Shenzhen University

zhuzhiqiang@szu.edu.cn+86 158 7062 8962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026