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Essential TremorVIM-CLTNCT02264925

Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives

A study testing Deep Brain Stimulation with Medtronic Activa PC+S systems in people with Essential Tremor, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Essential Tremor
What is being tested?
Deep Brain Stimulation with Medtronic Activa PC+S systems
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFrance
Study dates
Nov 2014to 19 Nov 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients suffering from severe and disabling ET with serious impact on their quality of life (QoL).
  • 18-70 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Bordeaux, France

    Bordeaux, 33076

Other trials in France

About this study

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.

Read the detailed description

Essential tremor (ET) is one of the most common adult movement disorders with a prevalence of 4% in the general population. Although several medications (primidone, beta-adrenergic blockers, benzodiazepines…) are commonly used, few of them are truly effective for controlling the severe forms of ET. Since 1987, an alternative has emerged with the development of high frequency deep brain stimulation (DBS) of the thalamic nucleus ventralis intermedius (VIM). This surgical technique now represents the gold standard treatment for tremor-disabled ET patients. Although VIM-DBS is clearly effective for treatment of essential tremor (ET) a partial loss of DBS effectiveness may occur over time in some patients. This loss of DBS effectiveness could be related to an adaptation of the local neuronal network to chronic stimulation (changes in synaptic plasticity). In order to avoid this problem, investigators plan to develop a intermittent mode of VIM stimulation using a new Medtronic device combining a DBS system with local field potential (LFPs) sensing capability. First, investigators propose to analyse VIM LFPs in order to define a tremor biomarker in 10 patients operated for severe ET. Thereafter, investigators will automatically detect this biomarker using a specific algorithm and use it to trigger stimulation at the onset of tremor only. Thus, this project will allow us to optimize DBS therapy in ET, by improving the longevity of implantable devices and avoiding the loss of efficacy previously reported

Being tested
Deep Brain Stimulation with Medtronic Activa PC+S systems
Keywords
Essential tremor, Deep brain stimulation (DBS), Ventral intermediate Thalamus (VIM), Local field potentials (LFPs), Closed loop therapy
Medical subject headings
Essential Tremor

What participants receive

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

  • Deep Brain Stimulation with Medtronic Activa PC+S systemsDevice

    Deep Brain Stimulation of VIM.

Study groups in NCT02264925
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalAll of included patients will receive a standard deep brain stimulation of the thalamus in order to reduce their essential tremor
Receives: Device: Deep Brain Stimulation with Medtronic Activa PC+S systems

What is being measured

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

  1. 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

    Measured: 3 month after implantation

  2. 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

    Measured: 12 month after implantation

Timeline

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

  1. First posted15 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion19 Nov 2020
  4. Study completion19 Nov 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264925
Sponsor's protocol ID
CHUBX 2013/15
Acronym
VIM-CLT
Status last verified
Aug 2021
First submitted
20 Jun 2014
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20927533

  • 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.

    PubMed 3329873

  • 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.

    PubMed 17922323

  • 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.

    PubMed 16029963

  • 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.

    PubMed 11569910

  • 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.

    PubMed 10853080

  • 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.

    PubMed 10084526

  • 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.

    PubMed 10675426

  • 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.

    PubMed 17343274

  • 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.

    PubMed 20466699

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation with Medtronic Activa PC+S systems in people with Essential Tremor, run by University Hospital, Bordeaux at 1 site in France.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 13 Aug 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LFPs records 3 month after implantation (time frame: 3 month after implantation). The study lists 2 primary outcomes in all. 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 NCT02264925, which also lists 10 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 13 Aug 2021.

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VIM-CLT Clinical Trial NCT02264925 | AzTrials