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| ID | Type | Description | Link |
|---|---|---|---|
| 270731 | Other Identifier | Integrated Research Application System (IRAS) |
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The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.
This study is a prospective, randomized, double-blind cross-over trials. Patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. Following this, the trial will be unblinded and open-label follow up will continue for another nine months. Device use as per standard practice continues after the end of the trial.
If the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclical Stimulation | Experimental | This group will undergo cyclical stimulation mode of stimulation |
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| Continuous Stimulation | Active Comparator | This group will undergo the standard continuous mode of stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott St Jude Medical Infinity 7 neurostimulator | Device | The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study |
| Measure | Description | Time Frame |
|---|---|---|
| Fahn-Tolosa-Marin Tremor Rating Scale - total score difference | Change in Fahn-Tolosa-Marin tremor rating scale at 6 months compared to baseline. Minimum score is 0 and maximum score is 84. Higher scores indicate worse tremor control | 6 months compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol five dimensions questionnaire (EQ-5D) difference | The total score of EQ-5D questionnaire at 6 months compared to baseline. Each dimension of the questionnaire has a minimum score of 1 and a maximum score of 5. Higher composite scores indicate increased levels of perceived problems | 6 months post activation compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kantharuby Tambirajoo, MD | Contact | 00442032991906 | kantharuby.tambirajoo@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Keyoumars Ashkan, MD | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31046186 | Background | Ferreira JJ, Mestre TA, Lyons KE, Benito-Leon J, Tan EK, Abbruzzese G, Hallett M, Haubenberger D, Elble R, Deuschl G; MDS Task Force on Tremor and the MDS Evidence Based Medicine Committee. MDS evidence-based review of treatments for essential tremor. Mov Disord. 2019 Jul;34(7):950-958. doi: 10.1002/mds.27700. Epub 2019 May 2. | |
| 20623768 |
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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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Patients will be randomized into 2 groups with either cyclical or continuous stimulation. Patients will cross-over to the 2nd mode of stimulation after 1 month and then continued on the preferred mode of stimulation for the 3rd month. Open label follow-up starts at this point and continues for another 9 months.
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This study adopts a blind design. Only the programmer is aware of the randomisation details and the parameters will be kept separately in order to keep others blind about the intervention. Unblinding of the study will occur at the 3rd month of the study.
| Beck's Depression Index questionnaire difference |
The total score of Beck's Depression Index questionnaire at 6 months compared to baseline. The minimum score is 0 and maximum score is 63. Higher scores indicate increasing severity of depression |
| 6 months post activation compared to baseline |
| Quality of Life in Essential Tremor (QUEST) questionnaire difference | The total score of Quality of Life in Essential Tremor questionnaire at 6 months compared to baseline. Minimum score is 0 and maximum score is 120 with higher scores indicating worse quality of life due to tremor | 6 months post activation compared to baseline |
| Satisfaction with Treatment (SWT) questionnaire difference | The difference in Satisfaction with Treatment outcomes at 6 months compared to baseline | 6 months post activation compared to baseline |
| Clinical Global Impression of Change (CGI) difference | The difference in Clinical Global Impression of change outcome at 6 months compared to baseline | 6 months post activation compared to baseline |
| Implantable Pulse Generator (IPG) power consumption and longevity | Total amount of implantable pulse generator consumption used compared between the 2 groups | 6 months compared to baseline |
| Flora ED, Perera CL, Cameron AL, Maddern GJ. Deep brain stimulation for essential tremor: a systematic review. Mov Disord. 2010 Aug 15;25(11):1550-9. doi: 10.1002/mds.23195. |
| 11391740 | Background | Koller WC, Lyons KE, Wilkinson SB, Troster AI, Pahwa R. Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Mov Disord. 2001 May;16(3):464-8. doi: 10.1002/mds.1089. |
| 12539209 | Background | Rehncrona S, Johnels B, Widner H, Tornqvist AL, Hariz M, Sydow O. Long-term efficacy of thalamic deep brain stimulation for tremor: double-blind assessments. Mov Disord. 2003 Feb;18(2):163-70. doi: 10.1002/mds.10309. |
| 28400200 | Background | Wharen RE Jr, Okun MS, Guthrie BL, Uitti RJ, Larson P, Foote K, Walker H, Marshall FJ, Schwalb J, Ford B, Jankovic J, Simpson R, Dashtipour K, Phibbs F, Neimat JS, Stewart RM, Peichel D, Pahwa R, Ostrem JL; SJM DBS ET Study Group. Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial. Parkinsonism Relat Disord. 2017 Jul;40:18-26. doi: 10.1016/j.parkreldis.2017.03.017. Epub 2017 Mar 30. |
| 30787161 | Background | Paschen S, Forstenpointner J, Becktepe J, Heinzel S, Hellriegel H, Witt K, Helmers AK, Deuschl G. Long-term efficacy of deep brain stimulation for essential tremor: An observer-blinded study. Neurology. 2019 Mar 19;92(12):e1378-e1386. doi: 10.1212/WNL.0000000000007134. Epub 2019 Feb 20. |
| 18616684 | Background | Hariz GM, Blomstedt P, Koskinen LO. Long-term effect of deep brain stimulation for essential tremor on activities of daily living and health-related quality of life. Acta Neurol Scand. 2008 Dec;118(6):387-94. doi: 10.1111/j.1600-0404.2008.01065.x. Epub 2008 Jul 8. |
| 16103000 | Background | Troster AI, Pahwa R, Fields JA, Tanner CM, Lyons KE. Quality of life in Essential Tremor Questionnaire (QUEST): development and initial validation. Parkinsonism Relat Disord. 2005 Sep;11(6):367-73. doi: 10.1016/j.parkreldis.2005.05.009. |