Cyclic Deep Brain Stimulation in Essential Tremor

NCT04260971 | Unknown

• 2 other identifiers: KCH20-025270731
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Keywords

Essential Tremor; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (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

  6 months compared to baseline

Secondary Outcomes (6)

• EuroQol five dimensions questionnaire (EQ-5D) difference

  6 months post activation compared to baseline

• Beck's Depression Index questionnaire difference

  6 months post activation compared to baseline

• Quality of Life in Essential Tremor (QUEST) questionnaire difference

  6 months post activation compared to baseline

• Satisfaction with Treatment (SWT) questionnaire difference

  6 months post activation compared to baseline

• Clinical Global Impression of Change (CGI) difference

  6 months post activation compared to baseline

Study Arms (2)

Cyclical Stimulation

EXPERIMENTAL

This group will undergo cyclical stimulation mode of stimulation

Device: Abbott St Jude Medical Infinity 7 neurostimulator

Continuous Stimulation

ACTIVE COMPARATOR

This group will undergo the standard continuous mode of stimulation

Device: Abbott St Jude Medical Infinity 7 neurostimulator

Interventions

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

Continuous Stimulation; Cyclical Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (8)

• 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.

  PMID: 31046186 BACKGROUND

• 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.

  PMID: 20623768 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.

  PMID: 11391740 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.

  PMID: 12539209 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.

  PMID: 28400200 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.

  PMID: 30787161 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.

  PMID: 18616684 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.

  PMID: 16103000 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Keyoumars Ashkan, MD

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kantharuby Tambirajoo, MD

CONTACT

00442032991906; kantharuby.tambirajoo@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 7, 2020
• Study Start: February 25, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)