Essential TremorNCT07774598
Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
A study testing Transcutaneous Afferent Patterned Stimulation in people with Essential Tremor, run by Ruijin Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Transcutaneous Afferent Patterned Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
Shanghai
Jun Liu, MD,PhD, 86-021-64370045, jly0520@hotmail.com
About this study
Official title: A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor
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.
Read more
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.
- Conditions
- Essential Tremor
- Being tested
- Transcutaneous Afferent Patterned Stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Afferent Patterned StimulationDevice
A non-invasive, wearable neuromodulation device that delivers transcutaneous afferent patterned stimulation (TAPS) to modulate neural circuits associated with essential tremor. The device is applied according to the study protocol over the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| TAPS Treatment | Experimental | Not described Receives: Device: Transcutaneous Afferent Patterned Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
Change in tremor severity from baseline to each post-treatment time point, assessed using the The Essential Tremor Rating Assessment Scale (TETRAS). The TETRAS score ranges from 0 to 64, with higher scores indicating more severe tremor.
Measured: Baseline; Day 1; 1 month; 3 months
Incidence of Adverse Events
Incidence, type, and severity of adverse events occurring after treatment initiation. Adverse events will be graded according to standard criteria (e.g., CTCAE)
Measured: 3 months
Secondary outcomes (8)
Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)
Change in activities of daily living from baseline to each post-treatment time point, assessed using the Blessed Functional Activities of Daily Living Scale (BF-ADL). The BF-ADL score ranges from 0 to 17, with higher scores indicating greater functional impairment.
Measured: Baseline; Day 1; 1 month; 3 months
Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])
Change in anxiety severity from baseline to each post-treatment time point, assessed using the Hamilton Anxiety Rating Scale (HAMA). The HAMA score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline; 1 month; 3 months
Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])
Change in depression severity from baseline to each post-treatment time point, assessed using the Hamilton Depression Rating Scale (HAMD). The HAMD score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline; 1 month; 3 months
Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])
Change in cognitive function from baseline to each post-treatment time point, assessed using the Montreal Cognitive Assessment (MoCA). The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline; 1 month; 3 months
Change in Cognitive Function (Mini-Mental State Examination [MMSE])
Change in cognitive function from baseline to each post-treatment time point, assessed using the Mini-Mental State Examination (MMSE). The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline; 1 month; 3 months
Change in EEG Alpha Band Power
Change in electroencephalogram (EEG) alpha band power (8-12 Hz) from baseline to each post-treatment time point.
Measured: Baseline; 1 month; 3 months
Change in Motor Evoked Potential (MEP) Amplitude
Change in motor evoked potential (MEP) amplitude from baseline to each post-treatment time point, measured using transcranial magnetic stimulation. MEP amplitude is measured in millivolts (mV), with higher values indicating greater corticospinal excitability.
Measured: Baseline; 1 month; 3 months
Change in Functional Connectivity (fMRI)
Change in functional connectivity between predefined brain regions from baseline to post-treatment, assessed using functional magnetic resonance imaging (fMRI).
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Dec 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774598
- Sponsor's protocol ID
- ET_TAPS
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor
- ClinicalTrials.gov ID
- NCT07774598
- Acronym / sponsor ID
- ET_TAPS
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAPS Treatment | Experimental | Device: Transcutaneous Afferent Patterned Stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Afferent Patterned StimulationA non-invasive, wearable neuromodulation device that delivers transcutaneous afferent patterned stimulation (TAPS) to modulate neural circuits associated with essential tremor. The device is applied according to the study protocol over the treatment period. | Device | TAPS Treatment |
Primary outcome
Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
Time frame: Baseline; Day 1; 1 month; 3 months
Change in tremor severity from baseline to each post-treatment time point, assessed using the The Essential Tremor Rating Assessment Scale (TETRAS). The TETRAS score ranges from 0 to 64, with higher scores indicating more severe tremor.
Incidence of Adverse Events
Time frame: 3 months
Incidence, type, and severity of adverse events occurring after treatment initiation. Adverse events will be graded according to standard criteria (e.g., CTCAE)
8 secondary outcomes
Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)
Time frame: Baseline; Day 1; 1 month; 3 months
Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])
Time frame: Baseline; 1 month; 3 months
Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])
Time frame: Baseline; 1 month; 3 months
Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])
Time frame: Baseline; 1 month; 3 months
Change in Cognitive Function (Mini-Mental State Examination [MMSE])
Time frame: Baseline; 1 month; 3 months
Change in EEG Alpha Band Power
Time frame: Baseline; 1 month; 3 months
Change in Motor Evoked Potential (MEP) Amplitude
Time frame: Baseline; 1 month; 3 months
Change in Functional Connectivity (fMRI)
Time frame: Baseline; 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Afferent Patterned Stimulation in people with Essential Tremor, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, MD,PhD (021-86-64370045, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score) (time frame: Baseline; Day 1; 1 month; 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.