Tremor Retrainer Software Application for Functional Tremor

NCT06257069 | Recruiting

• 1 other identifier: 230161
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?
2. 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?

Conditions

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

Keywords

Functional Tremor

Outcome Measures

Primary Outcomes (2)

• mHealth Application Usability Questionnaire

  Usability Questionnaire. Score range: 21-147 with higher scores indicating better usability

  Study visit 3

• Simplified Functional Movement Disorder Rating Scale

  Videorecorded severity scale. Score range: 0-54 with higher scores indicating greater severity (worse movements)

  Study visits 1-4

Other Outcomes (6)

• Adherence

  Study visit 3

• Clinical Global Impression Severity Scale - Clinician Rated

  Study visits 1-4

• Clinical Global Impression Improvement Scale - Clinician Rated

  Study visits 2-4

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All subjects will receive intervention with Tremor Retrainer smartphone application

Device: Tremor Retrainer Smartphone Application

Interventions

Tremor Retrainer Smartphone Application 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.

Intervention Arm

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 10 years and older, any gender, any race
• 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.
• Access to internet and a laptop or tablet with a videocamera.
• Informed consent obtained and signed
• Subject understands study procedures and is able to comply with study procedures for duration of study

You may not qualify if:

• Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor
• Cognitive impairment with previously diagnosed intellectual disability (IQ\<70) or dementia
• Hearing impairment not addressed by hearing aids
• Prior enrollment in clinical trial involving the Tremor Retrainer application

Sponsors & Collaborators

• University of Virginia: lead
• Child Neurology Foundation: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Jordan Garris

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Caballero, LCSW

CONTACT

434-297-5711; HTP5AW@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: January 17, 2024
• Primary Completion: October 31, 2025
• Study Completion: January 17, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data anticipated to be available in 2026.
• Access Criteria: Anonymized participant data will be publicly available.

Locations

US (1)