GyroGlove Use in Essential Tremor Patients

GyroGear

Status: Not yet enrolling

Conditions: Essential Tremor

Treatments: Device: GyroGlove; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05958030

CLIN-0001

Details and patient eligibility

About

This is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.

Full description

All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo).

In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove at home.

All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order.

The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Subject has been clinically diagnosed with ET
• Has either unilateral or bilateral tremor of the hand or predominantly hand as well as forearm
• Has a score of ≥ 2 in ADL activities 2, 3, 6 & 8 of the TETRAS ADL subscale (TRG, Sep 2021)
• Tremor in at least one hand causing water spillage during drinking

And

• Stable dosage of medications throughout the duration of the study, if applicable
• Ability to speak and read in the language that the trial documentation has been translated to.
• Ability to understand verbal instructions in the language that the trial documentation has been translated to.
• Ability to provide written informed consent to participate in the study
• Capacity to complete self-report outcome measures in the language that the trial documentation has been translated to

Exclusion criteria

• Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor

• Presence of tremor around the elbow and shoulder limiting participants to perform required test/procedure in the study

• Has implanted electrical medical device, e.g., pacemaker, defibrillator, or deep brain stimulator

• Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)

• Change in medication for tremor within 1 month prior to study enrolment

• Change in antidepressant medication within 3 months prior to study enrolment

• Has received botulinum toxin injection for hand tremor within 4 months prior to study enrolment

• Has been diagnosed with any of the following conditions affecting the hand and/or arm:

  • Fingers/Wrist joint defects or deformities or current skeletal injuries that prevent them from wearing the glove
  • Hand muscular deformities or weakness, e.g.: Myotonic Dystrophy, Autosomal Recessive Muscular Dystrophy limiting participant to perform required test/procedure in the study
  • Skin Conditions of the hand and forearm, e.g.: Eczema, Psoriasis, Extreme Skin Sensitivity
  • Growth or Development Defects of the hand, including but not limited to, Brittle Bone Disease, Triphalangeal Thumb.

• Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor.

• Neurological conditions aside from essential tremor that may affect the conduct of the study

• Peripheral neuropathy affecting the upper extremity

• Are participating or have participated in any interventional clinical trial or study in the last 30 days which may confound the results of this study, unless approved by the Sponsor

• Inability to follow simple instructions

• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

30 participants in 3 patient groups, including a placebo group

No Interventional

No Intervention group

Description:

Participants will perform protocol-specific tasks with no device

Investigational Device Arm

Experimental group

Description:

GyroGlove

Treatment:

Device: GyroGlove

Placebo Arm

Placebo Comparator group

Description:

Placebo

Treatment:

Device: Placebo