2025-09-05
minor
Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations, IPDSharing, References v17
Primary completion date2027-02→2027-09
Completion date2028-02→2028-09
Study sitescontacts updated at 1 of 1 site
Publications1 to 3 entries
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.
Lu [...]
Show 13 earlier versions
2021-07-13
minor
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2020-07-02
minor
Study Status, Study Description v12
Primary completion date2022-04→2023-02
Completion date2023-06→2024-02
Start date2012-11→2013-02-21
Study description-45 characters
[...] tremor must be evaluated by a movement disorder neurologist, Dr. Peter Hedera or Dr. Fenna Phibbs.
The neurologist will assess the severity of the tremor.
Yo [...] ry physician or outside neurologist must make a referral to Dr.the HederaVanderbilt orMovement Dr.Disorder PhibbsClinic for initial assessment.
For clinical trial participation, a [...] or SRS treatment.
The patient will meet with a neurosurgeon, Dr. Hong Yu, who will be involved in the SRS planning and procedure.
Pat [...] ave their physician refer the patient for consultation with Dr.the PeterMovement HederaDisorder or Dr. Fenna PhibbsClinic in the [...]
2019-07-16
minor
Study Status, Outcome Measures v11
Primary endpoints1 entry, revised
Tremor-related Quality of Life
2018-06-24
minor
Study Status, Study Description v10
Study description-19 characters
[...] ns.
The patient will undergo a neuropsychological evaluation by Dr. Scott Wylie prior to SRS treatment, which is the standard of care for p [...]
2018-05-30
minor
Study Status, Study Design, Arms and Interventions, Contacts/Locations v9
Primary completion date2019-04→2022-04
Completion date2019-06→2023-06
Enrollment target30→60
Study sitescontacts updated at 1 of 1 site
2018-03-26
minor
Study Identification, Study Status, Sponsor/Collaborators v8
Primary completion date2017-11→2019-04
Completion date2018-11→2019-06
Lead sponsorVanderbilt University→Vanderbilt University Medical Center
2016-10-31
minor
Study Status, Study Description, Contacts/Locations v7
Primary completion date2016-11→2017-11
Completion date2017-11→2018-11
Study description-6 characters
[...] RS treatment.
The patient will meet with a neurosurgeon, Dr.
Joseph NeimatHong Yu, who will be involved in the SRS planning and procedure.
Pa [...]
Study sitescontacts updated at 1 of 1 site
2015-12-09
minor
Study Status v6
Re-verified, no change to tracked fields
2015-06-01
minor
Study Status, Study Description, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2014-08-18
minor
Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2015-11→2016-11
Completion date2016-11→2017-11
Eligibility criteria-41 characters
[...] ation to the thalamus)
Inability to have a MRI of the brain
Taking an anticoagulant (except aspirin)
Prior surgical thalamotomy treatment (but contralateral deep [...]
Secondary endpoints1 to 2 entries
Neuropsychological Assessment
Study description+429 characters
[...] re and after SRS treatment at 3-month intervals for 1 year.
Currently we are only performing SRS treatment on one side of the brain (effects one side of the body) so the side with the worst tremor is treated.
Financial: All associated steps listed below are considered the Standard of Care to receive SRS treatment for tremor and are billed to the patient's in [...] Patients can receive this treatment without participating in the clinical trial questionnaires.
AllThere associatedis stepsno listedfinancial belowsupport, areno considered the Standard of Carecompensation, and areno billedtravel stipend av [...] [...]
Study sitescontacts updated at 1 of 1 site
2014-04-01
minor
Study Status, Study Description, Contacts/Locations v3
Study description+2,611 characters
[...] of tremor severity and usage of tremor-related medications.
Stereotactic Radiosurgery (SRS) is a standard-of-care treatment for patients with severe tremor.
This clinical trial is a questionnaire-based trial that only involves completion of 2 questionnaires at the consultation appointments with neurology and radiation oncology.
The questionnaires only take a [...] All patients interested in thisSRS clinicaltreatment trialfor tremor must havebe consultationsevaluated withby botha neurologymovement (disorder neurologist, Dr. Peter Hedera or Dr. Fenna Phibbs) and radiation oncology (Dr.
AnthonyThe Cmela [...] [...]
Study sitescontacts updated at 1 of 1 site
2013-04-12
minor
Study Status, Study Description, Contacts/Locations v2
Study description+60 characters
[...] essed.
All patients interested in this clinical trial should feel free to call the contact phone numbers listed below or have their physician refer the patient for consultation wit [...]
Study sitescontacts updated at 1 of 1 site
2013-01-22
minor
Study Status, Study Description, Contacts/Locations v1
Study description+1,473 characters
[...] tment approach and some patients are not surgical candidates for medical reasons.
Stereotactic radiosurgery (SRS) is a treatment that improvesuses high-energy highly-focused radiation (X-rays) to destroy a tiny region in the brain that causes tremor into patientsoccur.
This withregion ETis known as the ventral intermedius nucleus of the thalamus and PTis the same area targeted by surgical deep brain stimulator (DBS) treatment or neurosurgical operation (thalamotomy).
Multiple case series publications using Gamma Knife stereotactic radiation have been reported that show itstereotactic toradiosu [...] [...]
Study sitescontacts updated at 1 of 1 site