Health TrialsbyHealthPanel

Magnetoencephalography (MEG) Pilot Study

ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-84
SponsorUniversity of Florida

About this trial

The purpose of this research is to learn more about how the brain works in people with essential tremor, and how it changes after treatment with High-Intensity Focused Ultrasound (HiFU). Essential tremor is a movement disorder that causes shaking, usually in the hands, and can make everyday tasks difficult. HiFU is a treatment that uses focused sound waves to target a small area in the brain involved in tremor. In this study, the investigators aim to understand how this treatment affects the brain's networks by using safe, non-invasive tests such as brain imaging, brain wave recordings, and movement assessments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >50 years and <85 years

Refractory to at least 2 first line tremor medications

Skull Density Ratio (SDR) > = 0.35

MR/MEG incompatible implants and implantable devices (ex: pacemaker)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI and fMRI scans

    Diagnostic test

    functional MRI, diffusion tensor imaging, anatomical MRI

  • MEG

    Diagnostic test

    non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.

  • Sensor-based motor assessments

    Diagnostic test

    research-grade wearable sensors equipped with gyroscopes and accelerometers to precisely and accurately quantify patients' tremors. These sensors will be worn on the wrist or finger, capturing data as patients perform standardized tremor assessment tasks, such as spiral drawing task, writing task, commonly used in essential tremor evaluation. Gait and balance assessments will be conducted by synchronizing multiple sensors placed on the upper and lower extremities as well as the midline. Gait and balance data will be collected during tasks such as the 7-meter walk test, 360-degree turn test, and postural sway.

  • Clinical evaluations

    Other intervention

    vital signs, health status review, and neurological exam.

  • Questionnaires and rating scales that

    Other intervention

    daily functioning, mood, memory, and tremor

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Essential Tremor refractory to at least 2 first line tremor medicationsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound

Brain electrical activity will be recorded using magnetoencephalography (MEG) before treatment and at follow-up visits after treatment. MEG signals are collected as time-series data and processed to derive quantitative measures of functional brain connectivity that inform how interconnected different brain regions are. The primary outcome is the average change in these connectivity measures from pre-treatment baseline to post-treatment follow-up across participants.

Time frame
baseline to 7 months

Secondary outcomes

1

Correlation between change in tremor amplitude and change in MEG connectivity

Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived tremor amplitude (acceleration magnitude, m/s2) and the change in MEG connectivity metrics. Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

Time frame
Baseline (pre-treatment) to 6 months post-treatment
2

Correlation between change in tremor frequency and change in MEG connectivity

Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived tremor frequency (Hz) and the change in MEG connectivity metrics. Correlation coefficient (r) ranging from -1 to 1

Time frame
Baseline (pre-treatment) to 6 months post-treatment
3

Correlation between change in gait parameters and change in MEG connectivity

Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived gait parameters during a standardized walk test and the change in MEG connectivity metrics. Correlation coefficient (r) ranging from -1 to 1

Time frame
Baseline (pre-treatment) to 6 months post-treatment
4

Correlation between change in postural sway and change in MEG connectivity

Pearson correlation coefficient evaluating the correlation between the change in wearable balance sensor-derived postural sway and the change in MEG connectivity metrics. Correlation coefficient (r) ranging from -1 to 1

Time frame
Baseline (pre-treatment) to 6 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov
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