Essential Tremor Clinical Trial
Official title:
Cyclic Versus Continuous Deep Brain Stimulation in Essential Tremor
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Participant is at least 18 years of age 2. Participant has confirmed diagnosis of medically-refractory essential tremor 3. Participant meets criteria for implantation of DBS system 4. Participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed Exclusion Criteria: 1. Participant meets any contraindications for implantation of DBS system 2. Participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant 3. Participant is unwilling or unable to comply with all study required follow-up evaluations |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Ferreira JJ, Mestre TA, Lyons KE, Benito-León 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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Rehncrona S, Johnels B, Widner H, Törnqvist 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. — View Citation
Tröster 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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