NCT07774598 Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
| NCT ID | NCT07774598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-12-15 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the long-term efficacy and safety of non-invasive neuromodulation using transcutaneous afferent patterned stimulation (TAPS) in patients with essential tremor (ET). Essential tremor is a common movement disorder that can significantly impair daily functioning and quality of life. Pharmacological treatments are often limited by suboptimal efficacy or adverse effects, highlighting the need for alternative therapeutic approaches. In this study, eligible participants with essential tremor will receive TAPS treatment over a defined follow-up period. Clinical outcomes, including tremor severity, functional performance, and patient-reported outcomes, will be assessed longitudinally to evaluate treatment effectiveness. Safety will be monitored throughout the study by recording adverse events and device-related complications. The results of this study aim to provide clinical evidence regarding the long-term therapeutic potential and safety profile of TAPS as a non-invasive neuromodulation strategy for essential tremor.
Eligibility Criteria
Inclusion Criteria: * Adults aged ≥18 and \<75 years * Clinical diagnosis of essential tremor (ET), characterized by postural and/or kinetic tremor, primarily affecting one or both upper limbs, with or without involvement of other body regions (e.g., head, voice, or lower limbs) * At least one major hand task score ≥2 on the TETRAS (The Essential Tremor Rating Assessment Scale), and a score ≥3 on the Bain \& Findley Activities of Daily Living (BF-ADL) scale * Able and willing to provide written informed consent Exclusion Criteria: * Presence of implanted electronic medical devices (e.g., deep brain stimulator or cardiac pacemaker) * History of thalamotomy or other neurosurgical procedures for tremor * History of epilepsy * Current treatment with botulinum toxin for upper limb tremor * Skin lesions on the upper limb at the stimulation site (e.g., tumors, hemangiomas) * Neurological disorders affecting the upper limbs * Known allergy to device materials (e.g., silicone, cotton textiles) * Pregnant women * Intake of caffeine or excessive alcohol within 8 hours prior to enrollment * Severe cardiovascular or cerebrovascular diseases, or other significant neurological disorders * Inability to comply with study procedures or follow-up
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07774598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07774598 currently recruiting?
Yes, NCT07774598 is actively recruiting participants. Contact the research team at jly0520@hotmail.com for enrollment information.
Where is the NCT07774598 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07774598 clinical trial?
NCT07774598 is sponsored by Ruijin Hospital. The trial plans to enroll 50 participants.