NCT01734122

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
28mo left

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2013Sep 2028

First Submitted

Initial submission to the registry

November 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2013

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

14.5 years

First QC Date

November 20, 2012

Last Update Submit

September 5, 2025

Conditions

TremorEssential TremorParkinson DiseaseRadiosurgeryQuality of Life

Keywords

Stereotactic RadiosurgeryEssential TremorParkinsonian TremorQuality of LifeSeverity of Tremor

Outcome Measures

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.

    1 year

Secondary Outcomes (2)

  • Severity of Tremor

    1 year

  • Neuropsychological Assessment

    Baseline and 6 months post-treatment

Study Arms (2)

Essential Tremor

Patients with severe, medication-refractory Essential Tremor

Other: Questionnaires / Observational Assessments

Parkinsonian Tremor

Patients with severe, medication-refractory, tremor-dominant Parkinsons

Other: Questionnaires / Observational Assessments

Interventions

Questionnaires / Observational AssessmentsOTHER

Includes QUEST, PDQ-39, FTM, and Neuropsych evaluation

Essential TremorParkinsonian Tremor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This trial enrolls persons with essential tremor or Parkinsonian tremor that is inadequately controlled by medications.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (3)

  • Luo G, Neimat JS, Cmelak A, Kirschner AN, Attia A, Morales-Paliza M, Ding GX. Margin of error for a frameless image guided radiosurgery system: Direct confirmation based on posttreatment MRI scans. Pract Radiat Oncol. 2017 May-Jun;7(3):e223-e231. doi: 10.1016/j.prro.2016.08.006. Epub 2016 Aug 20.

    PMID: 27720703BACKGROUND

  • Khattab MH, Cmelak AJ, Sherry AD, Luo G, Wang L, Yu H, Hedera P, Phibbs FT, Lindsell CJ, Neimat J, Kirschner AN. Noninvasive Thalamotomy for Refractory Tremor by Frameless Radiosurgery. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):121-130. doi: 10.1016/j.ijrobp.2021.08.021. Epub 2021 Aug 25.

    PMID: 34454047BACKGROUND

  • Luo G, Cameron BD, Wang L, Yu H, Neimat JS, Hedera P, Phibbs F, Bradley EB, Cmelak AJ, Kirschner AN. Targeting for stereotactic radiosurgical thalamotomy based on tremor treatment response. J Neurosurg. 2021 Oct 29;136(5):1387-1394. doi: 10.3171/2021.7.JNS21160. Print 2022 May 1.

    PMID: 34715657BACKGROUND

Related Links

MeSH Terms

Conditions

TremorEssential TremorParkinson Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 27, 2012

Study Start

February 21, 2013

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

US(1)