Evaluating deep brain stimulation for essential tremor
The Swedish Essential Tremor (SWEET) Trial - A Multicentre Randomized Controlled Trial of Deep Brain Stimulation for Essential Tremor
NA · Karolinska Institutet · NCT03832712
This study is testing if deep brain stimulation can help people with essential tremor feel better compared to the best current medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT03832712 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effects of deep brain stimulation (DBS) against the best medical treatment for patients with essential tremor (ET) in a randomized, single-blinded controlled format. It will assess the efficacy of DBS targeting both the ventrolateral thalamus and a new target in the posterior subthalamic area. The study also seeks to map the optimal target areas for stimulation and evaluate the long-term effects of DBS on ET. By refining the approach to DBS, the trial hopes to improve outcomes for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of essential tremor, experiencing substantial incapacity and unsatisfactory response to medical therapy.
Not a fit: Patients with cognitive impairment or other significant co-morbidities that could affect the study outcomes may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with essential tremor, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown success with deep brain stimulation in treating other movement disorders, indicating potential for this approach in essential tremor, although this specific targeting is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg and 5 other locations
- 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)
Study contacts
- Principal investigator: Anders Fytagoridis, PhD — Karolinska Institutet
- Study coordinator: Anne-Louice Eriksson
- Email: annelouice.eriksson@vll.se
- Phone: +468907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Essential Tremor, Deep Brain Stimulation, Randomized Controlled Trial