directSTIM™ DBS System PMCF ET Study
Study Details
Study Description
Brief Summary
This is a prospective, multi-center, single arm post-market clinical follow-up study.
The present study investigates a CE-marked product 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study investigates the benefits and safety of the use of directSTIM DBS system within its Intended Use, to deliver Deep Brain Stimulation therapy to patients suffering from Essential Tremor 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb [3 months]
Mean difference between the most severe FTM ETRS performance subscale score (postural or kinetic) of the target limb 3 months post-implant between the stimulation OFF and stimulation ON states
Secondary Outcome Measures
- Proportions of Safety events observed [3 months]
Proportions of the following events from DBS implant through study completion: Adverse Events: Surgery-related Device-related Therapy-related Device deficiencies
- Change in total score on the Fahn Tolosa Marin Essential Tremor Rating Scale [3 months]
Mean difference between the total FTM ETRS score at 3 months post-implant between the stimulation OFF and stimulation ON states.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is 18 years of age or older.
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Patient with main tremor symptoms in upper limbs.
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Patient was referred for DBS surgery to treat Essential Tremor and chose the directSTIM DBS System
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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 diease)
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Patient accepts to abstain from caffeine for 8 hours and from alcohol for 12 hours before visit.
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Patient accepts to turn stimulation OFF for 1 hour prior to the 3-month follow-up visit.
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Patient is willing to provide a written informed consent.
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Patient is available for the study visit, and other study requirements.
Exclusion Criteria:
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Cognitive impairment, or any characteristic that would limit study candidate's ability to complete study assessments, such as:
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Active major psychiatric disorder (including clinically significant depression as rated by the clinician)
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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)
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Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker)
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Previous brain ablation/surgical procedure
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Neurological injury, evidence of supraspinal central nervous system disease
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History of seizures
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Diathermy
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Abuse of drugs or alcohol.
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Patient had botulinum toxin injection less than 6 months prior to enrollment
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Patient is participating in another clinical study that would confound data analysis.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Aleva Neurotherapeutics SA
Investigators
- Study Director: Alain Dransart, Aleva Neurotherapeutics SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLI-12082