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NCT03223623 · ClinicalTrials.gov registry record · NA

Pathophysiology of Focal Hand Dystonia

A NA study of Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT03223623 is a NA study of Dystonia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 32 participants, below the 539-participant average among 28 other Dystonia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03223623, a NA study of Dystonia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

Background: Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD. Objectives: To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD. Eligibility: Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age. Design: Participants will be screened with physical exam, neurological exam, and medical history. They may give a urine sample and will answer questions. Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days. Participants will have MRI scans. They will lie on a table that slides in and out of a scanner that takes pictures of their brain. They will do small tasks or be asked to imagine things during the scanning. Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with breaks. A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse. This affects brain activity. Participants may do small tasks during TMS. Participants will have the electrical activity of their muscles measured during TMS sessions. Small sticky pads will be attached to their hands and arms. Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers. They will also be asked to feel small plastic domes with ridges, that may cause discomfort.

Conditions Studied

Interventions

  • DEVICE TMS
  • DEVICE MRI
  • DEVICE VASO Imaging

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2017-12-12
Est. Completion 2022-05-18
Phase NA

What the Registry Record Tells You About NCT03223623

The ClinicalTrials.gov registry entry for NCT03223623 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 539-participant average among 28 other Dystonia trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dystonia appearing as the primary indexed condition, and to 3 interventions - of which TMS is the first listed.

NCT03223623 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03223623 about?

NCT03223623 is a clinical study titled "Pathophysiology of Focal Hand Dystonia". Background: Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia co...

What is the current status of trial NCT03223623?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2017-12-12. Estimated completion is 2022-05-18.

What conditions does trial NCT03223623 study?

This clinical trial studies the following conditions: Dystonia.

What interventions are being tested in trial NCT03223623?

The interventions under investigation include: TMS (DEVICE), MRI (DEVICE), VASO Imaging (DEVICE).

Who is sponsoring clinical trial NCT03223623?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03223623 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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