Temporal Interference Stimulation for Motor and Non-motor Symptoms in Parkinson's Disease
ConditionParkinson s Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
This study aims to evaluate the efficacy of tTIS treatment in improving motor function in patients with Parkinson's disease (PD), as well as its effects on mood, activities of daily living, sleep, cognition, and other functional domains. It also seeks to assess differences in treatment response among PD subtypes (tremor-dominant, rigidity-dominant, and mixed) and across disease stages (early stage, Hoehn and Yahr \[H\&Y\] stages 1-2, and mid-to-late stage, H\&Y stages 2.5-3). The study will enroll eligible PD patients and evaluate their condition using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the 39-item Parkinson's Disease Questionnaire (PDQ-39), the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Anxiety Rating Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), and a visual analog scale (VAS) for fatigue. Assessments will be performed before routine tTIS treatment, immediately after treatment, and at two and four weeks post-treatment, in order to analyze the therapeutic effect of tTIS in PD. This is an observational study without any intervention; all enrolled participants will receive standard medical care and health education.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, any gender.
Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria: the patient must (a) exhibit parkinsonism (bradykinesia plus rest tremor and/or rigidity); (b) not meet any of the MDS absolute
Disqualifiers
Disease duration ≥1 year, with stable clinical status.
Hoehn and Yahr stage 1.5-3; on a stable dose of levodopa or other dopaminergic medications, with a documented response to levodopa; treatment regimen remains unchanged throughout the study period.
The patient is scheduled to receive tTIS treatment.
The subject or legally authorized representative is able to provide written informed consent.
Trial population
Patients with a confirmed diagnosis of Parkinson's disease who are scheduled to undergo routine tTIS treatment and fulfill the study's inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
transcranial temporal interference stimulation (tTIS)
DeviceParticipants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.
Time frame
at baseline(before treatment), immediately after the patient receives tTIS treatment, and and at the two-week and four-week follow-ups after the completion of treatment.Secondary outcomes
1
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
The MDS-UPDRS Scale Part I Non-Motor Function score was used to assess the patient's Cognitive impairment, hallucinations and psychiatric symptoms, depression, apathy, impulse control disorders/dopamine dysregulation syndrome, sleep disorders, pain and other sensory symptoms, and urinary symptoms, with changes in the score reflecting the degree of improvement in those functions. The score for Part I ranges from 0 to 52 points. A higher score indicates greater impairment or more severe non-motor symptoms.
Time frame
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.2
MDS-UPDRS Scale Part II: Activities of Daily Living Score Changes
The MDS-UPDRS Scale Part II score was used to assess the patient's Activities of Daily Living, with changes in the score reflecting the degree of improvement in daily functions. The score for Part II ranges from 0 to 52 points. A higher score indicates greater impairment in daily activities.
Time frame
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.3
MDS-UPDRS Scale Part IV: Motor Fluctuations, Dyskinesias, and Dystonia Score Changes
The MDS-UPDRS Scale Part IV score was used to assess the patient's Motor Fluctuations, Dyskinesias, and Dystonia. The score for Part IV ranges from 0 to 24 points. A higher score indicates more severe motor complications caused by long-term levodopa therapy.
Time frame
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.4
Change in Score on the 39-item Parkinson's Disease Questionnaire (PDQ-39)
The 39-item Parkinson's Disease Questionnaire (PDQ-39) is used to assess the disease-specific health-related quality of life in patients with Parkinson's disease. The summary index score ranges from 0 to 100 points. A higher score indicates a poorer quality of life.
Time frame
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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