NCT03156517: Tremorstim

A Controlled Comparison of Two DBS Targets for Upper Extremity Action Tremor

Completed NA Last updated 27 October 2020

What this trial tests

NA trial testing Deep Brain Stimulation in Action Tremor in 45 participants. Completed in 5 December 2019.

Timeline

20 April 2014

Primary endpoint
3 June 2019

5 December 2019

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	20 April 2014
Primary completion	3 June 2019
Estimated completion	5 December 2019
Sites	1 location across Norway

Drugs / interventions tested

• Deep Brain Stimulation

Conditions studied

• Action Tremor — all drugs for Action Tremor →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 80, any sex, with Action Tremor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Action tremor of the arms can be an invalidizing symptom of diseases such as Essential Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that both are known to reduce action tremor of the arms. These two targets are called the VIM nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact).

Patients that are found eligible for DBS because of severe action tremor of the arms are invited to participate. After randomization, half of them are stimulated first in the VIM for 3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and at the end of each of these two 3-month periods, and eventual side-effects are registered. The best target is then selected and after another 6 months scoring is repeated. We intend to provide robust data about whether one of the two targets is superior to the other both regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if there is no significant difference between the two targets. We also carefully check the exact position of the active electrode contact in the brain and compare this with efficacy and safety evaluations. Long-term follow-up is planned after 3, 5, 7 and 10 years.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deep Brain Stimulation for Tremor: Update on Long-Term Outcomes, Target Considerations and Future Directions.
   Kremer NI, Pauwels RWJ, Pozzi NG, Lange F, et al · · 2021 · cited 29× · PMID 34441763 · DOI 10.3390/jcm10163468
2. Deep Brain Stimulation for Arm Tremor: A Randomized Trial Comparing Two Targets.
   Kvernmo N, Konglund AE, Reich MM, Roothans J, et al · · 2022 · cited 27× · PMID 35148020 · DOI 10.1002/ana.26317
3. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991