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NCT06073886 · ClinicalTrials.gov registry record · Phase 2

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

A Phase 2 study of Anxiety and Mild Traumatic Brain Injury, sponsored by University of California, Los Angeles.

Recruiting
Registry status
Phase 2
Development phase
75
Enrollment target
1
Study location

NCT06073886 is a Phase 2 study of Anxiety and Mild Traumatic Brain Injury that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 75 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06073886, a Phase 2 study of Anxiety and Mild Traumatic Brain Injury, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
Phase 2
Development phase
75 participants
Enrollment target
1
Study location

Study Summary

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

Interventions

  • DEVICE Active cTBS
  • DEVICE Inactive/Sham cTBS
  • BEHAVIORAL Imaginal exposure

Study Locations (1)

California

  • UCLA - Westwood, Los Angeles

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-03-06
Est. Completion 2027-01
Phase Phase 2

What the Registry Record Tells You About NCT06073886

The ClinicalTrials.gov registry entry for NCT06073886 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (83% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which Active cTBS is the first listed.

NCT06073886 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06073886 about?

NCT06073886 is a clinical study titled "Personalized Brain Stimulation to Treat Chronic Concussive Symptoms". The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occ...

What is the current status of trial NCT06073886?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2024-03-06. Estimated completion is 2027-01.

What conditions does trial NCT06073886 study?

This clinical trial studies the following conditions: Anxiety, Mild Traumatic Brain Injury, Headache, Concussion, Brain, Post-Concussion Syndrome.

What interventions are being tested in trial NCT06073886?

The interventions under investigation include: Active cTBS (DEVICE), Inactive/Sham cTBS (DEVICE), Imaginal exposure (BEHAVIORAL).

Who is sponsoring clinical trial NCT06073886?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06073886 being conducted?

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

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