Last updated: May 27, 2022
Sponsor: CognifiSense Inc.
Overall Status: Completed
Phase
N/A
Condition
Chronic Pain
Pain
Treatment
N/AClinical Study ID
NCT04468074
19-0526
1R43NR017575-01A1
Ages 21-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants aged 21 to 70 with Chronic Back Pain.
- Chronic Back Pain will be defined according to criteria established by recent NIH taskforce. Pain duration must be ≥ 3 months, with back pain being an ongoing problem forat least half the days of last 6 months; i.e., either pain every day for past 3months, or half or more of the days for past 6+ months.
- Subjects must rate pain intensity at ≥ 4/10 on Brief Pain Inventory (average pain overthe last week).
- Participants must also be comfortable and able to communicate via email, text message,or phone in English. Participants must also be comfortable using a video-conferencingservice such as Zoom to complete the on-line sessions.
Exclusion
Exclusion Criteria:
- Applicants, who are pregnant, planning pregnancy, or breastfeeding
- Back pain associated with compensation / litigation within 1 year.
- Leg pain greater than back pain (suggests neuropathic pain; may be less responsive topsychological therapy).
- Chronic pain other than chronic back pain.
- Diagnoses of schizophrenia, multiple personality dissociative identity disorder.
- History of major depressive disorder not controlled with medication or otherconditions that produce significant cognitive or emotional disability.
- History of substance abuse.
- Inability to undergo MRI (determined at screening; see XVI: Risks to Participants).
- Any clinically significant unstable medical abnormality or acute or chronic disease ofcardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonarydisease), hepatic, or renal systems; including: history of cardiovascular disease orissues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes;cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoidarthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equinasyndrome.
- History of seizure disorder, epilepsy, convulsions, or increased intracranial pressureanytime except pediatric febrile seizures.
- History of vertigo, dizziness, susceptibility to motion sickness
- History of head injury within 6 months,
- Unexplained, unintended weight loss of 'â• 20 lbs in past year.
- Self-reported history of (digital) eye strain or computer vision syndrome.
- Unable or unwilling to meet study attendance requirements.
- MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal inbody, claustrophobia, using the standard screen conducted by the MRI imagingfacility).
Study Design
Total Participants: 72
Study Start date:
June 09, 2020
Estimated Completion Date:
June 14, 2021
Connect with a study center
University of Colorado, Boulder
Boulder, Colorado 80301
United StatesSite Not Available

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