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Clinical Trials in Sweden / NCT03832712
Recruiting Not applicable

The Swedish Essential Tremor (SWEET) Trial

NCT03832712 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2018-06-30
Last updated
2022-05-25

Condition(s) studied

Essential Tremor

Investigational drug(s) / intervention(s)

Deep Brain StimulationBest Medical Treatment

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

Best Medical Treatment: Unselective β-blockers such as Propanolol

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Cognitive impairment; Co-morbidity or non-compliance likely to jeopardize the result or to confuse the evaluation; Normal surgical exclusion criteria.

Primary outcome measure(s)

  • Essential Tremor Rating Scale (ETRS) — Change from Baseline ETRS at 6 months
    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.

Trial sites (6)

FacilityCityRegionStatus
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

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Other trials for the same condition

Effects of Microelectrode-based Brain Stimulation in Humans Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03832712 on ClinicalTrials.gov ↗ ← All trials in Sweden