Stereotactic Radiosurgery in the Treatment of Essential Tremor

Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06821906

Acronym

EASIER

Enrollment

Registered

2025-02-12

Start date

2024-12-16

Completion date

2030-05-31

Last updated

2025-02-12

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

Conditions

Essential Tremor

Keywords

tremor, stereotactic radiosurgery, frameless radiosurgery, essenstial tremor, CyberKnife

Brief summary

The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients

Detailed description

The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years. After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms: 1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy 2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.

Interventions

RADIATIONStereotactic Radiosurgery

Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomised, open label, interventional research experiment

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded. * Insufficient tremor control despite the use of available pharmacotherapy methods. * Disqualification from the Deeply Brain Stimualtion procedure/lack of consent to perform it on the side qualified for Stereotactic Radiosurgery * Consent to participate in a clinical trial.

Exclusion criteria

* Age under 50 * Pregnancy * Duration of the disease less than 5 years * Dementia, psychosis or other condition that prevents giving informed consent to participate in the study * Poor general condition, serious comorbidities * Structural changes in the basal ganglia or major atrophic changes * Previous radiotherapy to the brain covering the potential treatment area * Medical contraindications to magnetic resonance imaging

Design outcomes

Primary

Measure	Time frame	Description
Treatment Efficacy	24 months	Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)

Secondary

Measure	Time frame	Description
Quality of life	24 months	The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire
Safety	24 months	Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Countries

Poland

Contacts

Primary ContactAleksandra Napieralska

aleksandra.napieralska@gliwice.nio.gov.pl48322788056

Backup ContactAgnieszka Szczyrba

agnieszka.szczyrba@gliwice.nio.gov.pl48322788001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026