Temporal interference stimulation targeting GPi or STN for motor symptoms in Parkinson's disease

The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study

This will test whether a 30-minute temporal interference brain stimulation session targeting either the GPi or STN can improve motor symptoms in people with Parkinson's disease who are off their medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Anhui Medical University (Academic / other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07572903 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, parallel-controlled three-arm trial comparing single-target transcranial temporal interference stimulation (tTIS) applied to the globus pallidus internus (GPi), the subthalamic nucleus (STN), or a sham condition. Parkinson's patients in the drug-off state (at least 12 hours after medication withdrawal) are randomly assigned to one of the three groups and receive a 30-minute stimulation session. Clinical motor symptoms are assessed before and after the intervention using standardized measures, while safety and adverse events are continuously monitored. The study also includes neurophysiological measures to explore how tTIS might affect brain circuits related to motor control.

Who should consider this trial

Good fit: Ideal candidates are people aged 40 or older with primary Parkinson's disease, MDS-UPDRS III score ≥8, Hoehn–Yahr stage 1–4, on a stable medication regimen for at least four weeks, and able to withhold medication for 12 hours for the off-medication assessments.

Not a fit: Patients with secondary parkinsonism, prior deep brain stimulation or major cranial surgery, severe focal brain injury or leukoencephalopathy, ferromagnetic implants, epilepsy, or other major neuropsychiatric disorders are unlikely to be eligible and may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive option to reduce motor symptoms or complement existing treatments for Parkinson's disease.

How similar studies have performed: Temporal interference stimulation is a relatively new, largely untested method in humans, while other noninvasive brain stimulation techniques (such as TMS and tDCS) have shown mixed and generally modest effects in Parkinson's disease.

Eligibility criteria

Inclusion Criteria:

1. Age \>= 40 years;
2. Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
3. No medication adjustment in the 4 weeks before and during each stimulation;
4. MDS-UPDRS III score \>= 8 points, Hoehn-Yahr score 1-4 points

Exclusion Criteria:

1. Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
2. Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
3. Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
4. Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
5. A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
6. Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
7. A history of drug abuse or drug use;
8. Participated in any clinical trial in the past 3 months;
9. Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;
10. Other situations that the researchers consider unsuitable for inclusion.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Junjun Wu

Conditions Parkinson s Disease; Temporal Interference Stimulation