Clinical trial NCT05795218: directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor
Official title: A Prospective, Multi-center, Single Arm, Observational, Post-market Clinical Follow-up Study on the Use of the directSTIM™ Deep Brain Stimulation System to Treat Essential Tremor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Essential Tremor
Keywords: Deep Brain Stimulation
Lead sponsor: Aleva Neurotherapeutics SA
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-one patients suffering from Essential Tremor, referred for DBS surgery, who chose directSTIM, will be enrolled in a minimum of 3 sites in Europe to collect primary safety and effectiveness variables baseline and 3 months post-surgery.

The sample size has been determined for the primary effectiveness endpoint. Study subjects will be representative of the target population since they will be recruited among patients who discussed the need and agreed with their clinician upon the implant of a DBS System to treat their motor symptoms caused by Essential Tremor.

Brief summary: This is a prospective, multi-center, single arm post-market clinical follow-up study.

The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care.

This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system.

Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria.

Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors.

After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care.

Study will be conducted at minimum 3 centers in Europe.

Detailed description: This study investigates the benefits and safety of the use of the directSTIM Deep Brain Stimulation (DBS) system within its intended use, to deliver DBS therapy to patients suffering from Essential Tremor (ET) whose motor symptoms are no longer optimally controlled through pharmaceutical treatment.

The objective of this study is to show that directSTIM is not inferior to competitor DBS Systems at alleviating postural or kinetic symptoms of Essential Tremor through the delivery of Deep Brain Stimulation therapy.

Data to be analyzed will be collected from ET patients referred for DBS surgery, who chose to get the directSTIM DBS System implanted after discussing its risks and benefits with their clinician.

All procedures involving the patient and the device follow the standard of care in place at the site for DBS.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older.
* Patient with main tremor symptoms in upper limbs.
* Patient was referred for DBS surgery to treat Essential Tremor and chose the directSTIM DBS System
* Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor with medication, for the worst limb (i.e. most affected by disease)
* Patient accepts to abstain from caffeine for 8 hours and from alcohol for 12 hours before visit.
* Patient accepts to turn stimulation off for 1 hour prior to the 3-month follow-up visit.
* Patient is willing to provide a written informed consent.
* Patient is available for the study visit, and other study requirements.

Exclusion Criteria:

* Cognitive impairment, or any characteristic that would limit study candidate's ability to complete study assessments, such as:

  * Active major psychiatric disorder (including clinically significant depression as rated by the clinician)
  * Patient had dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score \<24 or otherwise not capable of discernment)
  * Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker)
  * Previous brain ablation/surgical procedure
  * Neurological injury, evidence of supraspinal central nervous system disease
  * History of seizures
  * Diathermy
  * Abuse of drugs or alcohol.
* Patient had botulinum toxin injection less than 6 months prior to enrollment
* Patient is participating in another clinical study that would confound data analysis.

Primary outcomes:
measure: Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb
timeFrame: 3 months
Secondary outcomes:
measure: Proportions of Adverse Events and Device Deficiencies observed
timeFrame: 3 months
measure: Change in total motor score on the Fahn Tolosa Marin Essential Tremor Rating Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Münster
country: Germany
facility: Universitätsklinikum Münster
Study officials:
affiliation: Aleva Neurotherapeutics SA
name: Alexandre Michalis
role: STUDY_DIRECTOR
References: