Tremor Retrainer Software Application for Functional Tremor

NCT ID: NCT06257069

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2026-01-17

Brief Summary

The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:

1. Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?

2. Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?

Detailed Description

Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol.

The study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1.

For Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups.

For Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration.

For Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.

Conditions

Functional Movement Disorder; Functional Neurological Disorder; Functional Neurological Symptom Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

All subjects will receive intervention with Tremor Retrainer smartphone application

Group Type: EXPERIMENTAL

Tremor Retrainer Smartphone Application

Intervention Type: DEVICE

The Tremor Retrainer smartphone application uses the smartphone's built-in accelerometer to calculate a patient's tremor frequency when the smartphone is strapped to the patient's wrist. The application will provide auditory cues to the patient with a treatment frequency at 2/3 the patient's baseline tremor frequency for half a session, then 1/3 the patient's baseline tremor frequency for the second half of the session. Meanwhile, oscillatory movements will be continuously analyzed with frequency calculated and displayed relative to goal frequency, so that the patient receives continuous feedback via a visual dial as to whether they are meeting treatment goals. Intervention will consist of a one-week Tremor Retrainment Protocol.

Interventions

Tremor Retrainer Smartphone Application

The Tremor Retrainer smartphone application uses the smartphone's built-in accelerometer to calculate a patient's tremor frequency when the smartphone is strapped to the patient's wrist. The application will provide auditory cues to the patient with a treatment frequency at 2/3 the patient's baseline tremor frequency for half a session, then 1/3 the patient's baseline tremor frequency for the second half of the session. Meanwhile, oscillatory movements will be continuously analyzed with frequency calculated and displayed relative to goal frequency, so that the patient receives continuous feedback via a visual dial as to whether they are meeting treatment goals. Intervention will consist of a one-week Tremor Retrainment Protocol.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 10 years and older, any gender, any race

2. Functional tremor as defined by Espay and Lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment.

3. Access to internet and a laptop or tablet with a videocamera.

4. Informed consent obtained and signed

5. Subject understands study procedures and is able to comply with study procedures for duration of study

Exclusion Criteria

1. Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor

2. Cognitive impairment with previously diagnosed intellectual disability (IQ<70) or dementia

3. Hearing impairment not addressed by hearing aids

4. Prior enrollment in clinical trial involving the Tremor Retrainer application

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Child Neurology Foundation

UNKNOWN

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jordan F Garris

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan Garris

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah Caballero, LCSW

Role: CONTACT

HTP5AW@uvahealth.org

434-297-5711

Facility Contacts

Hannah Caballero, LCSW

Role: primary

HTP5AW@uvahealth.org

434-297-5711

Other Identifiers

230161

Identifier Type: -

Identifier Source: org_study_id