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The Swedish Essential Tremor (SWEET) Trial (SWEET)

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ClinicalTrials.gov Identifier: NCT03832712
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Umeå University
Uppsala University
Lund University
University Hospital, Linkoeping
Göteborg University
Information provided by (Responsible Party):
Anders Fytagoridis, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Tremor Procedure: Deep Brain Stimulation Drug: Best Medical Treatment Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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).
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: The Swedish Essential Tremor (SWEET) Trial - A Multicentre Randomized Controlled Trial of Deep Brain Stimulation for Essential Tremor
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Surgical
Participants randomized to surgery
 Procedure: Deep Brain Stimulation
Surgical implantation of intracranial leads for deep brain stimulation, extension cables and implantable pulse generator
Active Comparator: Medical
Participants randomized to best medical treatment
 Drug: Best Medical Treatment
Unselective β-blockers such as Propanolol


Outcome Measures
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Primary Outcome Measures :
  1. Essential Tremor Rating Scale (ETRS) [ Time Frame: 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.



Secondary Outcome Measures :
  1. Quality of life in ET (QUEST) [ Time Frame: Change from Baseline at 6 months ]
    Questionnaire Quality of Life in Essential Tremor Minimum score 0 (no self rated symptoms of ET) maximum 128 (maximum self rated symptoms of ET)

  2. electric energy consumption [ Time Frame: Change from Baseline at 6 months ]
    Pulse effective voltage (PEV) i s calculated för each operated patient


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832712


Contacts
Contact: Anne-Louice Eriksson +468907850000 annelouice.eriksson@vll.se

Locations
Sweden
Sahlgrenska University Hospital Not yet recruiting
Göteborg, Sweden
Contact: Thomas Skoglund, PhD         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Peter Zsigmond, PhD         
Lund University Hospital Recruiting
Lund, Sweden
Contact: Hjalmar Bjartmarz, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Anders Fytagoridis, PhD         
Sub-Investigator: Göran Lind, PhD         
Umeå University Hospital Recruiting
Umeå, Sweden
Contact: Patric Blomstedt, PhD         
Sub-Investigator: Marwan Hariz, PhD         
Akademiska Sjukhuset Recruiting
Uppsala, Sweden
Contact: Elena Jiltsova, MD         
Sponsors and Collaborators
Karolinska Institutet
Umeå University
Uppsala University
Lund University
University Hospital, Linkoeping
Göteborg University
Investigators
Study Chair: Patric Blomstedt, PhD Umeå Universitet
Principal Investigator: Anders Fytagoridis, PhD Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Anders Fytagoridis, Karolinska Institutet:
Study Protocol  [PDF] December 20, 2018

More Information
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Responsible Party: Anders Fytagoridis, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03832712     History of Changes
Other Study ID Numbers: 2017-238-31
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anders Fytagoridis, Karolinska Institutet:
Deep Brain Stimulation
Randomized Controlled Trial

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases