Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description below for more information.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be certified by a neurologist as having essential tremor or Parkinsonian tremor that is insufficiently controlled by medication alone.
Preference to receive radiation treatment for tremor treatment, rather than surgical DBS implantation or surgical thalamotomy
At least 18 years old
Disqualifiers
Contraindications to cranial radiation (such as prior radiation to the thalamus)
Inability to have a MRI of the brain
Prior surgical thalamotomy treatment (but contralateral deep brain stimulator [DBS] is permitted)
Estimated life expectancy less than 1 year
Trial population
This trial enrolls persons with essential tremor or Parkinsonian tremor that is inadequately controlled by medications.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires / Observational Assessments
Other interventionIncludes QUEST, PDQ-39, FTM, and Neuropsych evaluation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Essential Tremor1 intervention
Group B: Parkinsonian Tremor1 intervention
Trial outcomes
Primary outcomes
1
Tremor-related Quality of Life
The tremor-related quality of life for each patient will be assessed by self-assessment questionnaire at 3 month intervals for 1 year after treatment by stereotactic radiation.
Time frame
1 yearSecondary outcomes
1
Severity of Tremor
The severity of tremor will be assessed by objective measure (Fahn-Tolosa-Marin tremor rating scale) at 3 month intervals for 1 year following the stereotactic radiation treatment.
Time frame
1 year2
Neuropsychological Assessment
All patients will undergo a neuropsychological assessment (1-2 hr examination) at baseline and at 6 months post-treatment. This will assess any unanticipated changes in neuropsychological brain function.
Time frame
Baseline and 6 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov