NCT06035809 Sensory Motor Arousal Regulation Treatment (SMART) Study
| NCT ID | NCT06035809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2028-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-04-15 with a primary completion date of 2028-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will investigate whether a movement and body-based treatment can benefit adults with Post-traumatic Stress Disorder (PTSD). The treatment is called Sensory Motor Arousal Regulation Treatment, or "SMART", and study participation involves 8 sessions of SMART, as well as pre-treatment, post-treatment, and 3-month follow-up assessments.
Eligibility Criteria
Inclusion Criteria: 1. Adults, aged 18-65 2. A primary diagnosis of PTSD as determined by our pre-treatment assessment 3. Ability to provide informed consent 4. Fluency in written and spoken English (to be able to complete assessments) 5. Lives within 30km of London, ON Exclusion Criteria: 1. any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy) 2. history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident as assessed retrospectively by participant) 3. significant untreated medical illness 4. history of neurological or neurodevelopmental disorder 5. history of any pervasive developmental disorder 6. lifetime bipolar or psychotic disorder 7. alcohol/substance abuse or dependence within the last 3 months 8. extensive narcotic use (e.g., fentanyl, oxycodone, etc.) 9. anyone who would not be suitable for short-term treatment (as determined by our pre-treatment assessment) 10. suicide attempt in last 6 months
Contact & Investigator
Ruth Lanius, MD, PhD
PRINCIPAL INVESTIGATOR
Lawson Health Research/Western University/LHSC
Frequently Asked Questions
Who can join the NCT06035809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06035809 currently recruiting?
Yes, NCT06035809 is actively recruiting participants. Contact the research team at suzy.southwell@lhsc.on.ca for enrollment information.
Where is the NCT06035809 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06035809 clinical trial?
NCT06035809 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Ruth Lanius, MD, PhD at Lawson Health Research/Western University/LHSC. The trial plans to enroll 80 participants.
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