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Cyclic Deep Brain Stimulation in Essential Tremor

Primary Purpose

Essential Tremor

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Abbott St Jude Medical Infinity 7 neurostimulator
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring Essential Tremor, Deep Brain Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cyclical Stimulation

Continuous Stimulation

Arm Description

This group will undergo cyclical stimulation mode of stimulation

This group will undergo the standard continuous mode of stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Satisfaction with Treatment (SWT) questionnaire difference
The difference in Satisfaction with Treatment outcomes at 6 months 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
Implantable Pulse Generator (IPG) power consumption and longevity
Total amount of implantable pulse generator consumption used compared between the 2 groups

Full Information

First Posted
February 6, 2020
Last Updated
September 1, 2021
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04260971
Brief Title
Cyclic Deep Brain Stimulation in Essential Tremor
Official Title
Cyclic Versus Continuous Deep Brain Stimulation in Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential Tremor, Deep Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclical Stimulation
Arm Type
Experimental
Arm Description
This group will undergo cyclical stimulation mode of stimulation
Arm Title
Continuous Stimulation
Arm Type
Active Comparator
Arm Description
This group will undergo the standard continuous mode of stimulation
Intervention Type
Device
Intervention Name(s)
Abbott St Jude Medical Infinity 7 neurostimulator
Intervention Description
The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study
Primary Outcome Measure Information:
Title
Fahn-Tolosa-Marin Tremor Rating Scale - total score difference
Description
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
Time Frame
6 months compared to baseline
Secondary Outcome Measure Information:
Title
EuroQol five dimensions questionnaire (EQ-5D) difference
Description
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
Time Frame
6 months post activation compared to baseline
Title
Beck's Depression Index questionnaire difference
Description
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
Time Frame
6 months post activation compared to baseline
Title
Quality of Life in Essential Tremor (QUEST) questionnaire difference
Description
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
Time Frame
6 months post activation compared to baseline
Title
Satisfaction with Treatment (SWT) questionnaire difference
Description
The difference in Satisfaction with Treatment outcomes at 6 months compared to baseline
Time Frame
6 months post activation compared to baseline
Title
Clinical Global Impression of Change (CGI) difference
Description
The difference in Clinical Global Impression of change outcome at 6 months compared to baseline
Time Frame
6 months post activation compared to baseline
Title
Implantable Pulse Generator (IPG) power consumption and longevity
Description
Total amount of implantable pulse generator consumption used compared between the 2 groups
Time Frame
6 months compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is at least 18 years of age Participant has confirmed diagnosis of medically-refractory essential tremor Participant meets criteria for implantation of DBS system Participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed Exclusion Criteria: Participant meets any contraindications for implantation of DBS system Participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant Participant is unwilling or unable to comply with all study required follow-up evaluations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kantharuby Tambirajoo, MD
Phone
00442032991906
Email
kantharuby.tambirajoo@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyoumars Ashkan, MD
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kantharuby Tambirajoo, MD
Phone
0044 2032991906
Email
kantharuby.tambirajoo@nhs.net
First Name & Middle Initial & Last Name & Degree
Keyoumars Ashkan, MD
First Name & Middle Initial & Last Name & Degree
Kantharuby Tambirajoo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31046186
Citation
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.
Results Reference
background
PubMed Identifier
20623768
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.
Results Reference
background
PubMed Identifier
11391740
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. doi: 10.1002/mds.1089.
Results Reference
background
PubMed Identifier
12539209
Citation
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.
Results Reference
background
PubMed Identifier
28400200
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.
Results Reference
background
PubMed Identifier
30787161
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.
Results Reference
background
PubMed Identifier
18616684
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.
Results Reference
background
PubMed Identifier
16103000
Citation
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.
Results Reference
background

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Cyclic Deep Brain Stimulation in Essential Tremor

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