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Conventional Image Navigated High-Resolution Brain Electrical Stimulation for Essential Tremor Treatment

Conventional Image Navigated High-Resolution Brain Electrical Stimulation for Essential Tremor Treatment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108795
Enrollment
Unknown
Registered
2025-09-05
Start date
2024-05-23
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

essential tremor

Interventions

stimulated:high-resolution transcranial electrical stimulation

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years, with no gender restriction. 2. Diagnosis of essential tremor or essential tremor with additional characteristics, as defined by the Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson and Movement Disorder Society; 3. FTM-TRS score of 2 or higher for postural or intention tremor in the distal upper limb on either side. 4. Voluntary participation in the study, including signing a dated informed consent form, agreeing to adhere to research procedures, and cooperating with the entire research process.

Exclusion criteria

Exclusion criteria: 1. Severe Neurological Conditions: History of severe neurological diseases such as significant brain atrophy, brain injury, brain surgery, or cerebrovascular disease. 2. History of severe mental illness, including schizophrenia or mood disorders; 3. Critical Illness: Presence of a critical illness that may interfere with study procedures or confound the assessment of study endpoints. 4. Pregnant or breastfeeding individuals. 5. Exclusion Criteria Related to Magnetic Resonance Imaging (MRI) and Modeled Navigation: ? Persistent head shaking when lying down. ? Severe head deformity. ? Claustrophobia. ? Excessive body weight preventing entry into the MRI machine. ? Presence of metal implants, such as intracranial aneurysm clips, cardiac implantable electronic devices, cochlear implants, or metal-containing dental, orthopedic, or gynecological implants. 6. Exclusion Criteria Related to Efficacy Assessment: ? Previous receipt of deep brain stimulation (DBS) therapy or transcranial electrical stimulation (TES) therapy. ? Botulinum toxin injection received within the past year. ? Plans to undergo DBS treatment, TES treatment, botulinum toxin treatment, focused ultrasound treatment, or similar therapies during the follow-up period. ? Participation in other concurrent clinical trials. ? Any other circumstances deemed inappropriate for participation by the researcher.

Design outcomes

Primary

MeasureTime frame
Fahn-Tolosa-Marin Tremor Rating Scale score of part A, B, and C;Fahn-Tolosa-Marin Tremor Rating Scale total score;

Secondary

MeasureTime frame
Fahn-Tolosa-Marin Tremor Rating Scale lateral score;CCAS-Scale score;Fahn-Tolosa-Marin Tremor Rating Scale score of part B;BOLD in fMRI;Fahn-Tolosa-Marin Tremor Rating Scale score of part C;CGI score;Fahn-Tolosa-Marin Tremor Rating Scale score of part B+C;amplitude in EEG;tremor acceleration;Fahn-Tolosa-Marin Tremor Rating Scale score of part A+B +C;amplitude of tre;or analysis;Fahn-Tolosa-Marin Tremor Rating Scale score of part A;Fahn-Tolosa-Marin Tremor Rating Scale score of part A+B;GRC score;

Countries

China

Contacts

Public ContactWu Yiwen

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

wyw11380@rjh.com.cn+86 139 1623 5834

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026