The Swedish Essential Tremor (SWEET) Trial

Sponsor
Karolinska Institutet
Study ID
NCT03832712
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — PROCEDURE
    Surgical implantation of intracranial leads for deep brain stimulation, extension cables and implantable pulse generator
  • Best Medical Treatment — DRUG
    Unselective β-blockers such as Propanolol

Study Details

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

Key Dates

First listed
Feb 6, 2019
Start date
Jun 30, 2018
Status verified
May 2022
Primary completion
Jan 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgical
    Participants randomized to surgery
  • Active Comparator: Medical
    Participants randomized to best medical treatment

Primary Outcome Measure

Essential Tremor Rating Scale (ETRS) [ Time Frame: Change from Baseline ETRS at 6 months ]

Central Contacts

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