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NCT03050801 · ClinicalTrials.gov registry record · Phase 1
Functional Connectivity as a Biomarker of rTMS
A Phase 1 study of Traumatic Brain Injury, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT03050801: Completed Phase 1 study of Traumatic Brain Injury, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT03050801 is a Phase 1 study of Traumatic Brain Injury that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 68 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03050801, a Phase 1 study of Traumatic Brain Injury, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help improve connections between brain areas in healthy people. Researchers want to see if it can be useful in patients with memory problems after TBI. Objective: To see how repetitive transcranial magnetic stimulation can be used to improve the connections between parts of the brain and whether this will lead to changes in memory. Eligibility: Adults 18-50 years old with TBI who can speak and write in English. Healthy volunteers the same age and English ability. Design: Participants will be screened with a neurological exam and may have a urine pregnancy test. Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8 visits. At the visits, participants will have all or some of the following: * MRI for about 1 hour. Participants will lie in a machine that takes pictures in a magnetic field. Participants will do some memory tasks. * Memory and attention tasks with pictures and with a computer * Questions about their mental state and well-being * TMS: A wire coil is held on the scalp and a short electrical current passes through it. Participants will hear a click and feel a pulling or twitch. They may be asked to make simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this for about 20 minutes. A week after the last visit, some participants will return for a memory test.
Primary Outcome
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at sufficient intensity to trigger action potentials in nearby neurons.The motor threshold is defined as the minimum percentage of the stimulator output to elicit a motor evoked potential. Repetitive TMS (rTMS) was delivered at 100% of the motor evoked potential threshold with repeated magnetic puls
Conditions Studied
Interventions
- DEVICE rTMS
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-03-24 |
| Est. Completion | 2020-08-07 |
| Phase | Phase 1 |
What the finished NCT03050801 record still lists
NCT03050801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which rTMS is the first listed.
NCT03050801 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03050801 about?
NCT03050801 is a clinical study titled "Functional Connectivity as a Biomarker of rTMS". Background: Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help improve connections between brain areas in healthy people. Researchers want to see if it can be useful in pa...
What is the current status of trial NCT03050801?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2017-03-24. Estimated completion is 2020-08-07.
What conditions does trial NCT03050801 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT03050801?
The interventions under investigation include: rTMS (DEVICE).
Who is sponsoring clinical trial NCT03050801?
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 NCT03050801 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03050801's enrollment target sits among peer trials
68 102nd of 171 higher than 70 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury 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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