NCT02264925

Brief Summary

The objective of this study is to characterize through spectral analysis intra-thalamic local field potentials (LFPs) recorded through implanted DBS leads during periods with and without tremor in patients suffering from severe essential tremor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

6.1 years

First QC Date

June 20, 2014

Last Update Submit

August 6, 2021

Conditions

Essential Tremor

Keywords

Essential tremorDeep brain stimulation (DBS)Ventral intermediate Thalamus (VIM)Local field potentials (LFPs)Closed loop therapy

Outcome Measures

Primary Outcomes (2)

  • LFPs records 3 month after implantation

    in order to characterize the features of tremor-related thalamic activity during the initiation of movement-related tremor-induced activity

    3 month after implantation

  • LFPs records 12 month after implantation

    in order to characterize the features of tremor-related thalamic activity during the initiation of movement-related tremor-induced activity

    12 month after implantation

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

All of included patients will receive a standard deep brain stimulation of the thalamus in order to reduce their essential tremor

Device: Deep Brain Stimulation with Medtronic Activa PC+S systems

Interventions

Deep Brain Stimulation with Medtronic Activa PC+S systemsDEVICE

Deep Brain Stimulation of VIM.

Deep Brain Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from severe and disabling ET with serious impact on their quality of life (QoL).
  • years old
  • Free of evolutive and untreated psychiatric disorder
  • Tremor must be predominant in the upper limbs although it can affect the lower limbs, head and voice.
  • Affiliation to a social security system
  • Written informed consent signed by the participant and the investigator (prior to any examination required by research)

You may not qualify if:

  • Parkinsonian tremor
  • Pregnancy or lactating women
  • Severe co-morbidity (cardiac, renal or respiratory failures, evolutive cancer)
  • Impaired cognitive functions (score \<130 on Mattis scale).
  • Patients with severe atrophy or lesions on MRI
  • Depression (Beck \> 10)
  • Participation in another clinical research for 18 months (after surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bordeaux, France

Bordeaux, 33076, France

Location

Related Publications (10)

  • Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.

    PMID: 20927533BACKGROUND

  • Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.

    PMID: 3329873BACKGROUND

  • Blomstedt P, Hariz GM, Hariz MI, Koskinen LO. Thalamic deep brain stimulation in the treatment of essential tremor: a long-term follow-up. Br J Neurosurg. 2007 Oct;21(5):504-9. doi: 10.1080/02688690701552278.

    PMID: 17922323BACKGROUND

  • Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. doi: 10.1016/j.clinph.2005.05.009. Epub 2005 Jul 18.

    PMID: 16029963BACKGROUND

  • Garcia Ruiz P, Muniz de Igneson J, Lopez Ferro O, Martin C, Magarinos Ascone C. Deep brain stimulation holidays in essential tremor. J Neurol. 2001 Aug;248(8):725-6. doi: 10.1007/s004150170127. No abstract available.

    PMID: 11569910BACKGROUND

  • Hariz MI, Shamsgovara P, Johansson F, Hariz G, Fodstad H. Tolerance and tremor rebound following long-term chronic thalamic stimulation for Parkinsonian and essential tremor. Stereotact Funct Neurosurg. 1999;72(2-4):208-18. doi: 10.1159/000029728.

    PMID: 10853080BACKGROUND

  • Limousin P, Speelman JD, Gielen F, Janssens M. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor. J Neurol Neurosurg Psychiatry. 1999 Mar;66(3):289-96. doi: 10.1136/jnnp.66.3.289.

    PMID: 10084526BACKGROUND

  • Schuurman PR, Bosch DA, Bossuyt PM, Bonsel GJ, van Someren EJ, de Bie RM, Merkus MP, Speelman JD. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. N Engl J Med. 2000 Feb 17;342(7):461-8. doi: 10.1056/NEJM200002173420703.

    PMID: 10675426BACKGROUND

  • Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8. doi: 10.1002/mds.21412.

    PMID: 17343274BACKGROUND

  • Yoshida F, Martinez-Torres I, Pogosyan A, Holl E, Petersen E, Chen CC, Foltynie T, Limousin P, Zrinzo LU, Hariz MI, Brown P. Value of subthalamic nucleus local field potentials recordings in predicting stimulation parameters for deep brain stimulation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Aug;81(8):885-9. doi: 10.1136/jnnp.2009.190918. Epub 2010 May 12.

    PMID: 20466699BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • BURBAUD Pierre, MD-PhD

    University Hospital Bordeaux, France

    STUDY DIRECTOR

  • Nicolas LANGBOUR, PhD

    IMN CNRS UMR 5293, Université Bordeaux 2 Segalen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

October 15, 2014

Study Start

November 1, 2014

Primary Completion

November 19, 2020

Study Completion

November 19, 2020

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations

FR(1)