directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor

NCT05795218 | Terminated

• 1 other identifier: CLI-12082
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 5

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.

Conditions

Essential Tremor

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb

  The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic). Each body area is evaluated in Part A of the FTM ETRS, which is composed of 10 questions. The FTM ETRS utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The target limb (arm) will be identified at baseline for each patient as the limb most severely affected by tremors (highest score in postural or kinetic assessment in part A). The primary efficacy outcome is the mean percentage difference, 3 months post-implant, between the with and without stimulation states, as measured on the target limb identified at baseline, by the individual performance subscale score (i.e. postural or kinetic) on the FTM ETRS.

  3 months

Secondary Outcomes (2)

• Proportions of Adverse Events and Device Deficiencies observed

  3 months

• Change in total motor score on the Fahn Tolosa Marin Essential Tremor Rating Scale

  3 months

Interventions

Deep Brain Stimulation DEVICE

implant and DBS therapy with the directSTIM™ DBS system

Also known as: DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aleva Neurotherapeutics SA: lead

Study Sites (5)

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Hamburg

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Alexandre Michalis

  Aleva Neurotherapeutics SA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: April 3, 2023
• Study Start: June 21, 2021
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)