An interventional study of HD Study Electrode in Chronic Pain, Neuropathic Pain and Failed Back Surgery Syndrome, sponsored by Albany Medical College. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Albany Medical College · Not applicable, Interventional, and Device feasibility
Among 1,283 studies in Chronic Pain with a site in United States — 259 open to participants now, 350 under way, 8 of them phase 3. Chronic Pain · United States.
Among the 1,283 studies in Chronic Pain with a site in United States, this one is the 978th largest by enrollment of the 1,092 interventional ones that give a count, is one of 78 that started in 2022, is one of 802 with no phase, and was the 891st registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →259 of the 1,283 studies in Chronic Pain with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →1,283 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 81 · Phase 2 112 · Phase 3 73 · Phase 4 50
First in 1992; this study’s year is marked. 78 started in 2022.
Median enrollment 60 across the 1,092 interventional studies, 100 across the 189 observational. Of the 847 that completed or were terminated, 386 (46%) have results posted.
209 of 1,283 have an industry lead sponsor. The 10 most frequent:
Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Albany Medical College has 3 studies filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
138 of the studies in Chronic Pain with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05703178Phase 3Northwestern UniversityWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | 2026-11-30 |
| NCT06091202Phase 3Oregon Health and Science UniversityTele-Collaborative Outreach to Rural Patients With Chronic Pain | 2027-05-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT03984565Staci Gruber, Ph.D.PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product | 2026-11 |
Among the 1,283 studies in Chronic Pain with a site in United States, from their registry updates:
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care
Device: HD Study Electrode
The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Numeric Rating Scale
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
Time frame: 3 months
McGill Pain Questionnaire (MPQ)
Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.
Time frame: 3 month
Oswestry Disability Index (ODI)
This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
Time frame: 3 months
Pain Catastrophizing Scale (PCS)
Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.
Time frame: 3 months
Beck Depression Index (BDI)
This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63
Time frame: 3 months
PainDetect
Ensures patient's pain is neuropathic in nature
Time frame: Baseline
Ran from Jun 2022 to primary completion in Dec 2023, 18 months.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 18 months is close to that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Albany Medical College