Cyclic Deep Brain Stimulation in Essential Tremor

Essential Tremor Clinical Trial

Official title:

Cyclic Versus Continuous Deep Brain Stimulation in Essential Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260971
• Other study ID #: KCH20-025
• Secondary ID: 270731
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: King's College Hospital NHS Trust
• Contact: Kantharuby Tambirajoo, MD
• Phone: 00442032991906
• Email: kantharuby.tambirajoo[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Abbott St Jude Medical Infinity 7 neurostimulator
The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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

Outcome

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