Autopsy report · NCT03718325
Burst Spinal Cord Stimulation (Burst-SCS) Study
Cause of deathOther
“The study was terminated early due to data quality concerns and protocol integrity issues involving inadequate sham stimulation parameters and compromised participant blinding.”
Life of this trial
- Registered 5 months before it started.
- Ran for about 1 year before it stopped.
- 12 participants enrolled.
- Results were posted on the registry 5 years 8 months after it ended.
Vital statistics
- Status
- Terminated
- Phase
- Na
- Sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Conditions
- Pain, Chronic; Failed Back Surgery Syndrome
- Interventions
- Burst-SCS; Sham SCS
- Participants
- 12
- Sites
- 1
- Countries
- United States
Trials that died the same way
- A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia
“The study was terminated due to insufficient sample size and protocol compliance issue.” - Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
“The study was terminated due to excessive toxicity and low compliance to the protocol scheme.” - Saracatinib in Treating Patients With Prostate Cancer
“Per protocol, study was terminated due to low rate of randomized patients.” - Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
“Difficulty in recruiting and maintenance of blinding necessary for the trial”
Look deeper
- The official registry record (the source of truth)
- Record history: every change the sponsor made
- Open it in the database
Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.