Deep Brain Stimulation Trial for Chronic Pain
16
about 6.2 years
40–75
2 sites in CA, TX
What this study is about
Researchers are testing deep brain stimulation of the subgenual cingulate cortex as a treatment for chronic, medically refractory low back pain. The trial will use a randomized, double-blind crossover design to evaluate its feasibility and preliminary effectiveness.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Use Deep Brain Stimulation of the Subgenus Cingulate Cortex
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: At least 10% of study participants to experience one or more significant adverse events (SAEs), Change in at least 50% in pain scores on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20) compared to baseline., Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline.
Secondary: 50% improvement in McGill Pain Questionnaire (MPQ), Change in EuroQol 5-Domain (EQ-5D) Score, Change in Montreal Cognitive Assessment Score (MoCA), Change in Short-Form 36 (SF-36) quality of life questionnaire score., Change in the Hamilton Depression Rating Scale (HAM-D), Change in the NIH Pain Intensity Survey, Change in the NIH Toolbox Pain Interference Computer Adaptive Test (CAT), Change in the PROMIS Pain Behavior CAT
implantable