Skip to content

A randomized double-blind sham-stimulation controlled study on the efficacy and safety of transcutaneous afferent patterned stimulation therapy through wrist-worn device for adult patients with modest to severe tremor

A randomized double-blind sham-stimulation controlled study on the efficacy and safety of transcutaneous afferent patterned stimulation therapy through wrist-worn device for adult patients with modest to severe tremor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123301
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Essential Tremor, Parkinson Disease, neuronal intranuclear inclusion disease

Interventions

TAPES treatment:Using a device shaped like a therapeutic wristband and a wrist strap, electrodes on the wrist strap alternately deliver electrical stimulation to the median and radial nerves at the wr
Sham stimulation :Using a wristband and a bracelet with the same appearance, the interior of the wristband was damaged and could not generate effective electrical stimulation. Similarly, the current i

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >=18 years, with no gender preference; 2. Diagnosed with essential tremor, Parkinson's disease, NIID, or peripheral neuropathy accompanied by tremor; 3. At least one item in the TETRAS upper limb score is >=2 (for essential tremor, NIID, or peripheral neuropathic tremor), or at least one item in the UPDRS upper limb tremor score is >=2 (for Parkinson's disease); 4. Voluntarily participate in clinical trials and be able to sign the informed consent form; 5.Able to complete follow-up and evaluation questionnaires.

Exclusion criteria

Exclusion criteria: 1. History of implanted electronic medical devices, such as pacemakers, defibrillators, or deep brain stimulators; 2. Previous thalamotomy for the treatment of tremor, including stereotactic thalamotomy, gamma knife radiosurgery thalamotomy, and focused ultrasound thalamotomy; 3. Previous diagnosis or suspected diagnosis of epilepsy; 4. Pregnant or lactating women; 5. Skin swelling, infection, inflammation, or skin rash, open wound, or skin cancer at the stimulation site; 6. Peripheral neuropathy affecting the examination of the target upper limb; 7. Alcohol abuse; 8. Target upper limb tremor caused by causes other than essential tremor, Parkinson's disease, neuronal intranuclear inclusion disease, or peripheral neuropathy; 9. Use of antidepressants within 3 months before enrollment; 10. Botulinum toxin injection for hand tremor within 6 months before enrollment; 11. Consumption of alcohol or caffeine within 12 hours before enrollment; 12. Other reasons that led the investigator to consider the patient unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Tremor amplitude;

Secondary

MeasureTime frame
Tremor Power;The Essential Tremor Rating Assessment Scale score for upper extremities;UPDRSIII tremor score(M20,M21);Clinical Global Impressions Scale of Improvement;

Countries

China

Contacts

Public ContactWang Qin

Zhongshan hospital Fudan University

wang.qin@zs-hospital.sh.cn+86 139 1835 9398

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026