NCT03832712

Brief Summary

To evaluate the effect of deep brain stimulation (DBS) vs best medical treatment in essential tremor (ET) in a randomized, single-blinded controlled trial.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

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

Study Progress92%
Jun 2018Jan 2027

Study Start

First participant enrolled

June 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

7.6 years

First QC Date

January 11, 2019

Last Update Submit

May 24, 2022

Conditions

Essential Tremor

Keywords

Deep Brain StimulationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Essential Tremor Rating Scale (ETRS)

    Fahn S, Tolosa E, Marin C (1993) Clinical rating scale for tremor. In: Jankovic J, Tolosa E (eds) Parkinson´s disease and movement disorders. Urban and Schwarzenberg Munich, pp 271-280 Scale: Total sum 0-144 points. Contralateral Tremor (item 5/6) \& Handfunction (item 11-14) 0-28 points.

    Change from Baseline ETRS at 6 months

Secondary Outcomes (2)

  • Quality of life in ET (QUEST)

    Change from Baseline at 6 months

  • electric energy consumption

    Change from Baseline at 6 months

Study Arms (2)

Surgical

ACTIVE COMPARATOR

Participants randomized to surgery

Procedure: Deep Brain Stimulation

Medical

ACTIVE COMPARATOR

Participants randomized to best medical treatment

Drug: Best Medical Treatment

Interventions

Deep Brain StimulationPROCEDURE

Surgical implantation of intracranial leads for deep brain stimulation, extension cables and implantable pulse generator

Surgical
Best Medical TreatmentDRUG

Unselective β-blockers such as Propanolol

Medical

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of ET, as decided by the movement disorder specialist; Substantial incapacity; Duration of symptoms \> 5 years; Age 18 - 75; unsatisfying effect from β-blockers, or be unable to tolerate the medical therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sahlgrenska University Hospital

Gothenburg, Sweden

NOT YET RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Lund University Hospital

Lund, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, Sweden

RECRUITING

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

  • Patric Blomstedt, PhD

    Umeå Universitet

    STUDY CHAIR

  • Anders Fytagoridis, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Louice Eriksson

CONTACT

+468907850000annelouice.eriksson@vll.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Tremor is measured with the Essential tremor rating scale (ETRS) with focus on items 5/6 (hand tremor) \& 11-14 (hand function). ETRS is performed before surgery at baseline and at 6 months on/off med/stim. The evaluation is done blinded to the patients in the surgical group. The evaluation is documented on video (with the patient wearing a head cap) and segmented for blinded evaluation of two expert evaluators
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Study design: * Step 1 is designed as a randomized controlled trial in order to compare the effect of DBS (Group A) and medical treatment (Group B) on ET (Aim 1). * In step 2 - 4 the patients in group A are operated and group A and B joined into one single group. * Step 2 - all electrode contacts are individually analysed regarding chronic and acute stimulation effects in relation to their location in either the Vim or the cZi in order to decide which target is more effective (Aim 2). * Step 3 - Effects and side effects, with consideration to field of stimulation, are analyzed in relation to neighboring structures in order to map the whole area and delineate the optimal target points (Aim 3). * Step 4 - The long-term effect is evaluated in a non-randomized longitudinal study at 1, 3, 5, 10 years (Aim 4).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 11, 2019

First Posted

February 6, 2019

Study Start

June 30, 2018

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

SE(6)