Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07192536 (ANCHOR) for Chronic Pain, Post-traumatic Stress Disorder (PTSD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Accelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans (ANCHOR) Phase 4 30 Non-Invasive No Placebo Veterans Novel Treatment
In ...
Show MoreAccelerated Neuromodulation for Concurrent Post-Traumatic Stress Disorder (PTSD) & Chronic Pain in Veterans - Exploring Preliminary Efficacy and Feasibility
- ANCHOR
- Pro00083064
PTSD
chronic pain
Veterans
Theta burst stimulation
Brain stimulation
Neuromodulation
Military
Accelerated treatment protocol
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAccelerated Neuromodulation Treatment Intermittent theta burst stimulation (iTBS), is a non-invasive treatment that uses brief magnetic pulses to stimulate specific areas of the brain. This treatment delivers pulses in very short bursts that mimic natural brain rhythms, and may be effective in treating Post-Traumatic Stress Disorder (PTSD) and chronic pain. Each treatment takes approximately 3 minutes to complete. In this open label, single arm study, pa...Show More | Transcranial magnetic stimulation Intermittent theta burst stimulation (iTBS) will be delivered via the Magstim Horizon 3.0 Transcranial Magnetic Stimulation device. This device has been authorized by Health Canada (License No.: 111334, Type: System, Device class: 3 Device first issue date 2024-06-04, License name: HORIZON 3.0 TMS THERAPY SYSTEM) and is indicated for use in treating mild depressive disorder. The device will be used off-label as a pot...Show More |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score | The PCL-5 is a 20-item self-report checklist of Post-Traumatic Stress Disorder (PTSD) symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. A score greater than 33 is typically used to indicate severity sufficient for a PTSD diagnosis | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in Chronic Pain Grade Scale (CPGS) score | The CPGS assesses two dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions. Participants must score 'Grade I, II, or III' on the CPGS at screening to qualify for the study. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain. | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in Pain Disability Index (PDI) score | The PDI is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. In other words, how much pain is preventing them from doing what they would normally do or from doing it as well as they normally would. Participants will be asked to respond to each category indicating the overall impact of pain in their life, not just when pain is at its worst. The total PDI score can range from 0 to 70, a higher score indicating more disruption with functioning across a range of activities. | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Hamilton Depression Rating Scale (HAM-D) score | The Hamilton Depression Rating Scale (HAM-D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in Patient Health Questionnaire (PHQ-9) score | The PHQ-9 is a 9-item self-report questionnaire used to assess depression symptom severity. Depression symptoms are rated from 0 (not depression) to 27 (severe). | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in Hamilton Anxiety Rating Scale (HAM-A) score | The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 (no anxiety) to 56 (severe anxiety) | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in General Anxiety Disorder scale (GAD-7) score | The General Anxiety Disorder scale is a 7-item questionnaire used to measure symptoms of generalized anxiety disorder. Scores range from 0-21 with higher scores indicating more generalized anxiety | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
Change in Inventory of Psychosocial functioning (IPF) score | The IPF is a self-report instrument measuring PTSD-related functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. The IPF was developed to have high content validity, to not confound PTSD symptoms and related impairment, and to not require respondent attributions regarding the cause of impairment. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Higher scores indicate more impairment | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
ReadON Cognitive Test | Cognitive function, specifically executive functioning, processing speed, episodic memory, and working memory, will be assessed using the ReadON Cognitive Test (Orange Neurosciences, Kingston, ON, Canada). Unlike standardized paper tests with a single total score, the ReadON test uses an algorithm to provide a comprehensive profile across multiple cognitive domains. | Baseline to End of Treatment (end of week 1), Follow up Assessments (week 3, week 6 after nil-treatment) |
NeuroCatch® Platform | NeuroCatch® Platform (NCP; NeuroCatch Inc., Surrey, BC, Canada) will be used to complement as an objective measure of cognitive function. NCP is an easy-to-use, objective, rapid neuro-physiological brain function assessment system, licensed by Health Canada as a Class II medical device. The platform provides acquisition, display, analysis, storage, reporting, and management of EEG and event related potential (ERP) information including the N100, P300 and N400 measures of brain function | From baseline visit to end of treatment visit (end of week 1) |
Program Feasibility will be assessed using the Effectiveness Framework | Efficacy/effectiveness will be assessed using results from the clinician- and participant-reported Post-Traumatic Stress Disorder (PTSD) and chronic pain symptoms measured as primary outcome measures (PCL-5 and CPGS), comparing changes from baseline to end of treatment (end of week 1). | Through study completion, an average of 1 year |
Program Feasibility will be assessed using the Adoption Framework | Adoption will be assessed as the perceived ease of protocol administration (for clinicians) and program adherence (for participants). | Through study completion, an average of 1 year |
Program Feasibility will be assessed using the Implementation and Maintenance framework | Implementation and maintenance will be assessed upon qualitative reports from the study team and participants regarding barriers and facilitators to help inform future program implementation efforts | Through study completion, an average of 1 year |
Adults (>19years age) with symptoms of both post-traumatic stress disorder (PTSD) and chronic pain, confirmed by clinical interview and rating scales (CAPS-5 & CPGS) performed at screening visit
a. Participants must score either 'Moderate' or 'Severe' on the CAPS-5 scale, and 'Grade I, II, or III' on the CPGS to qualify
Any sex and gender identity
Willing and able to attend all study visits and adhere to treatment plan, including the use of a personal computer to complete at-home questionnaires
Able to understand the informed consent form, study procedures and willing to participate in study
Able to perform the testing required by the study
Exhibiting significant suicide risk, as defined by:
- a. suicidal ideation as indicated by items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past six months, at screening visit
- demonstrating suicidal behaviours or non-suicidal self-injury within the past six months, or;
- clinical assessment of significant suicidal risk or risk of self-injury during participant interview
Participants who are pregnant, nursing, or planning a pregnancy
Participants who engage in sexual intercourse which could result in pregnancy, and who do not agree to use a highly effective contraceptive method throughout their participation in the study
Any other clinically significant neurological, psychiatric, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial
Individuals who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators, as well as metallic implants such as electrodes, stents, clips, pins, plates, screws, braces, or other metallic objects such as shrapnel or permanent jewelry.
The presence of ferrous metal pins or plates in or near the head (within 30 cm of the coil). Including implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, or other implants.
Individuals who have history of epilepsy or unexplained seizure history.
Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure
Any defects in the neurocranium (e.g. after skull trepanation)
Skin diseases of the scalp
Contraindications for NeuroCatch Platform:
Clinically documented hearing issues (e.g., in-ear hearing problems or punctured ear drum)
In-ear hearing aid or cochlear implant, hearing device
Lack of fluency in the English language
Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Legion Veterans Village Research FoundationBritish Columbia