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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
No history of musculoskeletal impairment or neurological disease
Clinical diagnosis of PTSD for individuals in the PTSD group.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 30 and 31
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no history of muscle, bone, or nerve diseases.
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I have been diagnosed with PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 30 and 31
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 30 and 31 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neurons
Changes in Neural Connections: Regional activation
Secondary outcome measures
Acoustic Startle response
Behavior Therapy
Changes in Measures of skin conductive response
+1 more

Trial 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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,411 Total Patients Enrolled
Michael Borich, PhDPrincipal InvestigatorEmory University

Media Library

Continuous theta burst stimulation (cTBS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05560113 — N/A
Post-Traumatic Stress Disorder Research Study Groups: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory Cortex, Sham cTBS
Post-Traumatic Stress Disorder Clinical Trial 2023: Continuous theta burst stimulation (cTBS) Highlights & Side Effects. Trial Name: NCT05560113 — N/A
Continuous theta burst stimulation (cTBS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560113 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I take part in this research if I qualify?

"This study requires 66 individuals that have PTSD, are aged 18-65, and meet the following prerequisites: Being able to comprehend and sign informed consent forms, a willingness to participate in the trial itself, no past medical history of neurological diseases or muscular skeletal impairments, finally, a clinical diagnosis of PTSD for people who hope to be in the PTSD group."

Answered by AI

Are there positions available in this trial for willing participants?

"According to the latest information on clinicaltrials.gov, this study is no longer looking for participants. The trial was first posted on 1/1/2023 and was last updated on 9/26/2022. There are, however,428 other trials that are still recruiting patients."

Answered by AI

What are the goals of this research project?

"The primary outcome of this study is to assess changes in neural connections regional activation. This will be done over a Study Day 30 and 31 timeframe. The secondary outcomes include ECG, which is defined as heart rate and heart-rate variability (HRV) that will be measured using the ECG module of the BIOPAC system. One 5mm Ag/AgCl electrode will be placed on the chest above the right clavicle while another electrode is placed on the chest under the left side of the ribcage., Changes in Measures of skin conductive response, which is defined as Skin conductance response (SCR)"

Answered by AI

Are middle-aged individuals being sought out for this research?

"The trial's enrollment requirements state that potential patients must be aged between 18-65."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~44 spots leftby Dec 2028