NCT01517087

Studying Motor Neuron Tests

Completed Last updated 12 March 2021

What this trial tests

trial in Healthy Subjects in 47 participants. Completed in 25 November 2020.

Timeline

1 February 2012

Primary endpoint
25 November 2020

25 November 2020

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	47
Start date	1 February 2012
Primary completion	25 November 2020
Estimated completion	25 November 2020
Sites	1 location across United States

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →
• Magnetic Resonance Imaging — all drugs for Magnetic Resonance Imaging →
• Central Nervous System — all drugs for Central Nervous System →
• Volunteer — all drugs for Volunteer →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

35 and older, any sex, with Healthy Subjects or Magnetic Resonance Imaging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People with motor neuron disorders have changes in the parts of the brain that control movement. Some tests that are currently used to study these changes are magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS give the same results if done at different times in the same person. Researchers want to see if these tests produce different results if given to healthy adults on two separate occasions.

Objectives:

\- To test the reliability of different tests of the brain used to study motor neuron disorders.

Eligibility:

* \<TAB\>Healthy individuals at least 35 years of age who have no history of neurological disorders and take no medications.
* \<TAB\>Pregnant women may not participate.

Design:

* Participants will be screened with a medical history and physical exam.
* Participants will have two testing visits 1 to 6 months apart.
* The first visit will have three parts. The first part is a neurological exam to test strength, sensation, reflexes, and coordination of movement. The second part will be TMS tests. The third part will involve an MRI scan to study the parts of the brain that control movement.
* At the second visit, participants will have MRI scanning only.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Longitudinal imaging in &lt;i&gt;C9orf72&lt;/i&gt; mutation carriers: Relationship to phenotype.
   Floeter MK, Bageac D, Danielian LE, Braun LE, et al · · 2016 · cited 67× · PMID 27995069 · DOI 10.1016/j.nicl.2016.10.014
2. Impaired corticopontocerebellar tracts underlie pseudobulbar affect in motor neuron disorders.
   Floeter MK, Katipally R, Kim MP, Schanz O, et al · · 2014 · cited 53× · PMID 25008395 · DOI 10.1212/wnl.0000000000000693
3. Cerebro-cerebellar connectivity is increased in primary lateral sclerosis.
   Meoded A, Morrissette AE, Katipally R, Schanz O, et al · · 2015 · cited 37× · PMID 25610792 · DOI 10.1016/j.nicl.2014.12.009
4. Cortical hyperexcitability in patients with C9ORF72 mutations: Relationship to phenotype.
   Schanz O, Bageac D, Braun L, Traynor BJ, et al · · 2016 · cited 31× · PMID 26799151 · DOI 10.1002/mus.25047
5. Loss of functional connectivity is an early imaging marker in primary lateral sclerosis.
   Clark MG, Smallwood Shoukry R, Huang CJ, Danielian LE, et al · · 2018 · cited 20× · PMID 30299161 · DOI 10.1080/21678421.2018.1517180
6. Longitudinal changes in resting state networks in early presymptomatic carriers of C9orf72 expansions.
   Shoukry RS, Waugh R, Bartlett D, Raitcheva D, et al · · 2020 · cited 13× · PMID 32769055 · DOI 10.1016/j.nicl.2020.102354
7. Longitudinal changes in network homogeneity in presymptomatic C9orf72 mutation carriers.
   Waugh RE, Danielian LE, Shoukry RFS, Floeter MK. · · 2021 · cited 7× · PMID 33421737 · DOI 10.1016/j.neurobiolaging.2020.11.014