NCT03760406

Brief Summary

Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

November 26, 2018

Last Update Submit

February 21, 2025

Conditions

Essential Tremor

Keywords

Essential TremorDeep brain stimulationVentro-intermediate nucleus of the thalamusTargetingAsleep surgery

Outcome Measures

Primary Outcomes (1)

  • Change of Fahn-Tolosa-Marin (FTM) scale score

    Scale global range : min=0 / max=160 Higher values represent worse tremor

    Before and 3 month after DBS surgery

Secondary Outcomes (7)

  • Accelerometry recordings : spectral analysis

    Before and 3 month after DBS surgery

  • Accelerometry recordings : calculation of the total accelerometry power

    Before and 3 month after DBS surgery

  • Surgical complications

    Up to 3 month after DBS surgery

  • Device complications and dysfunction

    Up to 3 month after DBS surgery

  • Neurostimulation-related side effects

    Up to 3 month after DBS surgery

  • +2 more secondary outcomes

Study Arms (1)

Severe essential tremor treated by DBS

EXPERIMENTAL
Procedure: Opti-VIM targeting in DBS surgery

Interventions

Opti-VIM targeting in DBS surgeryPROCEDURE

DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©). The VIM coordinates will be calculated with the probabilistic model that have been developed.

Severe essential tremor treated by DBS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe essential tremor despite the optimal medical management
  • Age between 18 and 75 years
  • Normal MRI scan
  • Mattis Dementia Rating Scale (MDRS) score ≥ 130
  • Affiliation to the social security
  • Signed informed consent

You may not qualify if:

  • Depression (Beck Depression Inventory scale \> 20)
  • Contra-indication to surgery or general anesthesia
  • Cerebral atrophy on MRI scan
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Antoine BENARD, MD

    USMR CHU de Bordeaux

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 30, 2018

Study Start

March 18, 2019

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

FR(2)