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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03300856
Other study ID # 999917170
Secondary ID 17-N-N170
Status Completed
Phase
First received
Last updated
Start date October 4, 2017
Est. completion date July 19, 2018

Study information

Verified date July 2018
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

TMS stands for transcranial magnetic stimulation. It is a non-invasive way to stimulate the brain. It helps researchers study the nervous system. TMS can assess central motor conduction time (CMCT). That can be used to diagnose some diseases. It can also show how well treatments are working. Researchers want to study the records of people who have already had TMS. They want to see how it relates to the results of diagnostic studies.

Objectives:

To study the results of transcranial magnetic stimulation in certain neurological disorders. To create a descriptive analysis of the results.

Eligibility:

Records that are already in the NINDS database

Design:

The study will not enroll any participants.

Researchers will search the database for certain terms. These include TMS, CMTC, and motor evoked potentials. This will identify records of people who had TMS for diagnosis.

Using data from the records, researchers will calculate CMCT. They will note other data that relate to CMCT.

Researchers will analyze their findings. They will write a review article.

Personal data will be removed from all the records before the findings are analyzed.


Description:

Objective- To retrospectively study the results of transcranial magnetic stimulation (TMS) in various neurological disorders and create a descriptive analysis of the results.

Study population- Existing records of patients within the NINDS database who have had TMS performed to measure central motor conduction time (CMCT).

Design-

- Retrospective descriptive analysis.

- The NINDS EMG Database will be queried using terms such as TMS, CMCT, and MEP (motor evoked potentials) to identify EMG reports on patients who underwent TMS for diagnosis

- Within these reports peripheral motor conduction time (PMCT), the cortical motor evoked potential (MEP) latency and amplitude will be used to calculate CMCT, clinical patient factors pertinent to estimation of CMCT as well clinically significant physical exam findings will be recorded as well.

- Clinical diagnoses and neurological exams will be extracted from medical records

- Patient identifiers will be de-linked after compiling data from medical records

Outcome measures

- Results of CMCT using TMS in different diagnoses will be summarized for different neurologic disorders and correlated to clinical exam measures documented in previous records


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date July 19, 2018
Est. primary completion date July 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility - INCLUSION CRITERIA:

1. Patients who were seen in the NINDS EMG section for diagnostic TMS studies

2. Patients tested between 1998 and 2017

3. Greater than or equal to age 18.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Summary of central motor conduction studies in neurological disorders Study completion
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