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Stereotactic Radiosurgery in the Treatment of Essential Tremor

ConditionEssential Tremor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Radiosurgery

    Radiation

    Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

  • Stereotactic Radiosurgery

    Radiation

    Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: AActive comparator 1 intervention
Group B: BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Efficacy

Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)

Time frame
24 months

Secondary outcomes

1

Quality of life

The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire

Time frame
24 months
2

Safety

Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Sklodowska-Curie National Research Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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