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Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease

ConditionParkinson's Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 50-85 years, male or female.

Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.

Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.

Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.

Disqualifiers

Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.

Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.

Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.

Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • real transcranial temporal interference stimulation

    Device

    tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.

  • sham transcranial temporal interference stimulation

    Device

    The sham stimulation is administered using the same procedure as the real tTIS.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: the experimental groupExperimental treatment 1 intervention
Group B: the control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes of motor function in PD

the scores of UPDRS III \[OFF\])

Time frame
Changes from baseline after 5 days of intervention (Day 5)

Secondary outcomes

1

Changes of motor function in PD

the scores of UPDRS III \[OFF\] and \[ON\]

Time frame
Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
2

Changes of Motor Complications in PD

the scores of UPDRS IV

Time frame
Day 5, Day 15, Day 35
3

Assessment of changes in cognition

the scores of MoCA

Time frame
Day 5, Day 15, Day 35
4

Assessment of changes in anxiety

the scores of HAMA

Time frame
Day 5, Day 15, Day 35

Other outcomes

1

Changs of brain connectivity in the PD brain

functional magnetic resonance imaging (fMRI)

Time frame
After 5 days of intervention relative to baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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