Clinical trial NCT06343285: Upper Limb Tremor Reduction in Essential Tremor Patients
Official title: Upper Limb Tremor Reduction in Essential Tremor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Encora, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 71
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Three different arms in a randomized order
Primary purpose: TREATMENT

Brief summary: This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.

Detailed description: A prospective, randomized, blinded clinical trial. Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. Subjects will complete two rounds of assessments each day.

Arm 1: Inactive stim Arm 2: Stim therapy utilizing a specific dermatome Arm 3: Stim therapy utilizing a tailored frequency

Eligibility criteria: Inclusion/Exclusion:

Inclusion Criteria:

1. Between the ages of 22 and 80 years of age
2. A diagnosis of essential tremor (definite or probable based on TRIG criteria)
3. At least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating
4. Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
5. Stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study

Randomization Inclusion Criteria

1. During the Baseline evaluation period, a median tremor score of \> 2 on at least one hand as assessed by the TETRAS finger to nose task, the duck wing task, OR the Archimedes Spiral AND
2. During the Baseline evaluation period, a median score of \> 3 on any one of the subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL)

Exclusion Criteria:

1. Previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, or focused ultrasound)
2. Use of botulinum toxin for treatment to hand tremor within six months of enrollment
3. Suspected or diagnosed epilepsy or other seizure disorder
4. Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
5. Pregnant
6. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
7. Numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome)
8. Known allergy to silicone
9. Subjects are unable or unwilling to comply with the protocol requirements
10. Subject is part of a vulnerable population who is unable to give Informed Consent for reasons of incapacity, dementia, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
11. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Primary outcomes:
measure: Tolerability (Rate of Subject-Assessed Comfort with Stimulation)
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Safety (Rate of Adverse Events)
timeFrame: At the end of the 5-day treatment period in all randomization arms
Secondary outcomes:
measure: Bain & Findley Activity of Daily Living (BF-ADL) #2
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: BF-ADL #4
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: BF-ADL #17
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: BF-ADL #21
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Patient Global Impression of Change (PGI-C)
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Clinician Global Impression of Change (CGI-C)
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Tremor power as measured by gyroscope
timeFrame: At the end of the 5-day treatment period in all randomization arms
Other outcomes:
measure: The Essential Tremor Rating Scale (TETRAS) #2.4
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: TETRAS #2.6
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: TETRAS #2.8
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Clinician Global Impression of Severity (CGI-S)
timeFrame: At the end of the 5-day treatment period in all randomization arms
measure: Tremor power as measured by accelerometer
timeFrame: At the end of the 5-day treatment period in all randomization arms
Locations:
city: Cambridge
country: United States
facility: Encora Therapeutics
state: Massachusetts
Study officials:
affiliation: Encora Therapeutics
name: Kristi Winterfeldt, MSHS
role: PRINCIPAL_INVESTIGATOR
References: