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The purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. The primary endpoint will be preserved tremor control with the alternating group compared with standard treatment using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved activities of daily living measures as well as preserved tremor control as quantified by motion sensor data.
This study has one primary aim: To determine if alternating DBS stimulation parameters on a weekly basis will be superior at preserving tremor control compared with usual stimulation (non-alternating stimulation) in ET patients with VIM DBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | In the placebo cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks, but they will be blinded to the fact that their group A and group B are equivalent. |
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| Treatment | Active Comparator | In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternating stimulation | Other | Two different, but equally efficacious, settings will be determined for each subject. The settings will differ by a minimum of two of the following parameters: electrode configuration, voltage, frequency and pulse width. The different settings will be named Setting A and Setting B. The treatment cohort will receive both Setting A and Setting B that will differ by the parameters listed above. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks | Through study completion, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TETRAS ADLs scale at 12 weeks | Through study completion, at 12 weeks | |
| Motion sensor data to detect tremor | Patients will wear motion sensor device to detect tremor characteristics | Two weeks after initial visit; and again at weeks 10-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon D Anderson, MPAS, PA-C | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Science and University | Portland | Oregon | 97239-3098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24096713 | Background | Baizabal-Carvallo JF, Kagnoff MN, Jimenez-Shahed J, Fekete R, Jankovic J. The safety and efficacy of thalamic deep brain stimulation in essential tremor: 10 years and beyond. J Neurol Neurosurg Psychiatry. 2014 May;85(5):567-72. doi: 10.1136/jnnp-2013-304943. Epub 2013 Oct 4. | |
| 20927533 | Background | Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8. |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Placebo | Other | The control cohort will receive Setting A but Setting B will be identical to Setting A. |
|
| 19911883 | Background | Zhang K, Bhatia S, Oh MY, Cohen D, Angle C, Whiting D. Long-term results of thalamic deep brain stimulation for essential tremor. J Neurosurg. 2010 Jun;112(6):1271-6. doi: 10.3171/2009.10.JNS09371. |
| 23582712 | Background | Shih LC, LaFaver K, Lim C, Papavassiliou E, Tarsy D. Loss of benefit in VIM thalamic deep brain stimulation (DBS) for essential tremor (ET): how prevalent is it? Parkinsonism Relat Disord. 2013 Jul;19(7):676-9. doi: 10.1016/j.parkreldis.2013.03.006. Epub 2013 Apr 11. |
| 18826350 | Background | Pilitsis JG, Metman LV, Toleikis JR, Hughes LE, Sani SB, Bakay RA. Factors involved in long-term efficacy of deep brain stimulation of the thalamus for essential tremor. J Neurosurg. 2008 Oct;109(4):640-6. doi: 10.3171/JNS/2008/109/10/0640. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |