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New treatment option for PTSD
Official title Deep Brain Stimulation for Refractory PTSD
ClinicalTrials.gov ID: NCT06705296
What this study is testing
- What it's testing
- Treatment refractory PTSD is a chronic and debilitating psychiatric disorder associated with high morbidity. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Female or Male patients between age 18-70
- Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
- Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective...
- Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores≥ 50.
- A pattern of chronic stable PTSD lasting at least 1 year.
You likely can't join if
- Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
- Active neurologic disease, such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
- Current suicidal ideation
- Any contraindication to MRI or PET scanning
- Likely to relocate or move out of the country during the study's duration.
See the full eligibility criteria
- Female or Male patients between age 18-70
- Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
- Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective serotonin reuptake inhibitors, b) cognitive behavioral therapy, c) other...
- Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores≥ 50.
- A pattern of chronic stable PTSD lasting at least 1 year.
- Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols.
- Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
- Active neurologic disease, such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
- Current suicidal ideation
- Any contraindication to MRI or PET scanning
- Likely to relocate or move out of the country during the study's duration.
- Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
- Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.