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NCT04606095 · ClinicalTrials.gov registry record · NA
Explosive Synchronization of Brain Network Activity in Chronic Pain
A NA study of Healthy Volunteers and Fibromyalgia, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04606095: Recruiting NA study of Healthy Volunteers and Fibromyalgia, sponsored by University of Michigan.
NCT04606095 is a NA study of Healthy Volunteers and Fibromyalgia that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 150 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606095, a NA study of Healthy Volunteers and Fibromyalgia, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).
Primary Outcome
Correlation between EEG alpha band degree and frequency will be calculated as the primary outcome measure. Brain related EEG data will be analyzed using computer software designed for EEG data as well as Statistical Package for the Social Sciences (SPSS).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST EEG
- DIAGNOSTIC_TEST Neuroimaging EEG/fMRI (Aim 1)
- DEVICE HD-tDCS treatments
- DEVICE Sham HD-tDCS treatments
- DIAGNOSTIC_TEST Neuroimaging EEG/fMRI (Aim 3)
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2026-07-20 |
| Phase | NA |
What NCT04606095 shows while recruiting
NCT04606095 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which EEG is the first listed.
NCT04606095 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04606095 about?
NCT04606095 is a clinical study titled "Explosive Synchronization of Brain Network Activity in Chronic Pain". This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional asse...
What is the current status of trial NCT04606095?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-11-13. Estimated completion is 2026-07-20.
What conditions does trial NCT04606095 study?
This clinical trial studies the following conditions: Healthy Volunteers, Fibromyalgia.
What interventions are being tested in trial NCT04606095?
The interventions under investigation include: EEG (DIAGNOSTIC_TEST), Neuroimaging EEG/fMRI (Aim 1) (DIAGNOSTIC_TEST), HD-tDCS treatments (DEVICE), Sham HD-tDCS treatments (DEVICE), Neuroimaging EEG/fMRI (Aim 3) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04606095?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606095 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04606095's enrollment target sits among peer trials
150 57th of 283 higher than 225 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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