NCT00500994

Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures

Completed EARLY_PHASE1 Last updated 16 May 2025

What this trial tests

EARLY_PHASE1 trial testing MRI in Movement Disorders in 254 participants. Completed in 13 December 2022.

Timeline

5 October 2007

Primary endpoint
13 December 2022

13 December 2022

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	basic science
Enrollment	254
Start date	5 October 2007
Primary completion	13 December 2022
Estimated completion	13 December 2022
Sites	2 locations across United States

Drugs / interventions tested

• MRI — full drug profile →

Conditions studied

• Movement Disorders — all drugs for Movement Disorders →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 99, any sex, with Movement Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.

Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.

Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.

Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.

Healthy volunteers may have blood drawn for genetic testing or fMRI or both.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Classification of Functional Movement Disorders with Resting-State Functional Magnetic Resonance Imaging.
   Waugh RE, Parker JA, Hallett M, Horovitz SG. · · 2023 · cited 6× · PMID 35570651 · DOI 10.1089/brain.2022.0001