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Behavioural Intervention
cTBS for PTSD
N/A
Recruiting
Led By Michael Borich, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 30 and 31
Summary
This trial will test if a non-invasive brain intervention can reduce the risk of developing PTSD after a traumatic event.
Who is the study for?
This trial is for adults who can consent and have been clinically diagnosed with PTSD. They should be willing to participate and not have musculoskeletal or neurological diseases. It's not for those with TMS or MRI contraindications, minors, pregnant women, prisoners, people outside the age range set by the study, those with dementia signs, on psychoactive meds recently, major head trauma survivors, neurodegenerative disorder patients or recent substance abusers.
What is being tested?
The trial tests if disrupting memory consolidation using non-invasive brain stimulation (cTBS) after a traumatic event can lessen fear responses and lower PTSD risk. Participants will receive either real cTBS or a sham (fake) treatment to compare effects on fear memories.
What are the potential side effects?
While specific side effects are not listed here for cTBS in this context of treating PTSD symptoms post-trauma exposure; generally cTBS may cause discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 30 and 31
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 30 and 31
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neurons
Changes in Neural Connections: Regional activation
Secondary study objectives
Acoustic Startle response
Behavior Therapy
Changes in Measures of skin conductive response
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory CortexExperimental Treatment1 Intervention
Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at the Center for Systems Imaging- Emory University Hospital (CSI-EUH) and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.
Group II: Sham cTBSPlacebo Group1 Intervention
Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at CSI-EUH and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,700 Previous Clinical Trials
2,604,532 Total Patients Enrolled
Michael Borich, PhDPrincipal InvestigatorEmory University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am within the specified age range for the trial.I do not have current symptoms of psychosis or bipolar disorder.I have no history of muscle, bone, or nerve diseases.I haven't taken any drugs recently that affect brain function or learning.I have no health issues that prevent me from undergoing TMS or MRI.I have been diagnosed with PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory Cortex
- Group 2: Sham cTBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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