3 ms·
> Impossible that it would receive ethical approval > The fact the patient knows she has a myriad of doctors looking at her, and that she had to undergo an ext
by smt88 5y ago
> Impossible that it would receive ethical approval
> The fact the patient knows she has a myriad of doctors looking at her, and that she had to undergo an extremely invasive and unique procedure means we cannot separate the intervention from the response.
Deep brain stimulation has undergone many such trials[1]. I'm not sure why this would be such an ethical barrier when we have much more risky and permanent procedures (various surgeries, for example) that can undergo ethical trials.
Methodology summary from trial linked below:
"We conducted a 6-month double-blind, randomized, sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation. After more than 3 months of stable remission, patients were randomly assigned to 2 treatment arms: the ON-OFF arm, which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months, and the OFF-ON arm, which involved sham stimulation for 3 months followed by active stimulation for 3 months."
1. https://pubmed.ncbi.nlm.nih.gov/25652752/ https://pubmed.ncbi.nlm.nih.gov/25652752/