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NCT07078422Toboroz

Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 24.

Rövid összefoglaló (regiszter, angolul)

Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use. 2. Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions. 3. Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
80 (tervezett)
Első benyújtás
2025. ápr. 9.
Kezdés
2025. jan. 1.
Elsődleges befejezés
2025. dec.
Fő szponzor
Encora, Inc.
Betegségek
Parkinson-kór
NCT-szám
NCT07078422

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 80
  • 2025. jan. 1. és az elsődleges befejezés (2025. dec.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
  • History of psoriasis, eczema or atopic dermatitis at the stimulation site
  • History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy
  • Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study.
  • Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
  • History of psoriasis, eczema or atopic dermatitis at the stimulation site
  • History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy
  • Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study

Egyéb

  • Pregnant women
  • Participant unable to communicate with sponsor/investigator and staff
  • Pregnant women
  • Participant unable to communicate with sponsor/investigator and staff

Kiket keres a vizsgálat

  • Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.
  • Mentally competent to understand and able to perform written, informed consent to participate in the study
  • A diagnosis of either ET or PD as determined by clinical history
  • Moderate to severe upper limb tremor
  • Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
  • Mentally competent to understand and able to perform written, informed consent to participate in the study
  • For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
  • For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
  • For ET subjects, at least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
  • For PD subjects, a score \> 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of \> 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter
  • Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation
  • For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits)
  • A wrist circumference of 6.0 - 8.1 inches

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Encora Therapeutics
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CambridgeEgyesült ÁllamokToboroz

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