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Essential TremorNCT04260971

Cyclic Deep Brain Stimulation in Essential Tremor

A study testing Abbott St Jude Medical Infinity 7 neurostimulator in people with Essential Tremor, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Essential Tremor
What is being tested?
Abbott St Jude Medical Infinity 7 neurostimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
25 Feb 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kantharuby Tambirajoo, MD contact

00442032991906

kantharuby.tambirajoo@nhs.net

United Kingdom1 site, 1 recruiting

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

    Kantharuby Tambirajoo, MD, 0044 2032991906, kantharuby.tambirajoo@nhs.net

    Keyoumars Ashkan, MD

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Abbott St Jude Medical Infinity 7 neurostimulator
Keywords
Essential Tremor, Deep Brain Stimulation
Medical subject headings
Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott St Jude Medical Infinity 7 neurostimulatorDevice

    The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study

Study groups in NCT04260971
Study groupRoleWhat they receive
Cyclical StimulationExperimentalThis group will undergo cyclical stimulation mode of stimulation
Receives: Device: Abbott St Jude Medical Infinity 7 neurostimulator
Continuous StimulationActive comparatorThis group will undergo the standard continuous mode of stimulation
Receives: Device: Abbott St Jude Medical Infinity 7 neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months compared to baseline

Secondary outcomes (6)

  1. 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

    Measured: 6 months post activation compared to baseline

  2. 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

    Measured: 6 months post activation compared to baseline

  3. 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

    Measured: 6 months post activation compared to baseline

  4. Satisfaction with Treatment (SWT) questionnaire difference

    The difference in Satisfaction with Treatment outcomes at 6 months compared to baseline

    Measured: 6 months post activation compared to baseline

  5. Clinical Global Impression of Change (CGI) difference

    The difference in Clinical Global Impression of change outcome at 6 months compared to baseline

    Measured: 6 months post activation compared to baseline

  6. Implantable Pulse Generator (IPG) power consumption and longevity

    Total amount of implantable pulse generator consumption used compared between the 2 groups

    Measured: 6 months compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start25 Feb 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260971
Sponsor's protocol ID
KCH20-025
Other IDs
270731
Status last verified
Sep 2021
First submitted
6 Feb 2020
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31046186

  • 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.

    PubMed 20623768

  • 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.

    PubMed 11391740

  • 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.

    PubMed 12539209

  • 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.

    PubMed 28400200

  • 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.

    PubMed 30787161

  • 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.

    PubMed 18616684

  • 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.

    PubMed 16103000

Questions about this trial

What is this clinical trial studying?

A study testing Abbott St Jude Medical Infinity 7 neurostimulator in people with Essential Tremor, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kantharuby Tambirajoo, MD (00442032991906, kantharuby.tambirajoo@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fahn-Tolosa-Marin Tremor Rating Scale - total score difference (time frame: 6 months compared to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260971, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.

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