Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial

Summary & key facts

Researchers tested a home-based brain stimulation treatment for people with moderate major depression. In a carefully controlled 10-week study, 174 adults were randomly sent either real stimulation or a fake (sham) version and did supervised 30-minute sessions at home. People getting the real stimulation improved a bit more on a standard depression questionnaire than those getting sham, both groups improved, and the treatment was reported to be safe and acceptable with no extra dropouts.

Key facts:

• This was a fully remote, carefully controlled trial that randomly assigned 174 adults with a current, moderate depressive episode to either active or sham home-based brain stimulation.
• The treatment lasted 10 weeks. Sessions were 30 minutes each. For the first 3 weeks people did five sessions per week, then three sessions per week for the next 7 weeks.
• About 87 people were in each group. The average age was about 37 years and the group had moderate depression at the start based on a standard rating scale.
• On the main depression scale, the active stimulation group improved by about 9 points and the sham group improved by about 7 points. The extra improvement with active treatment was small but unlikely to be due to chance.
• Both groups showed noticeable improvement, which means some benefit came from factors other than the electrical stimulation itself or from doing the sessions at home.
• There were no differences in how many people stopped treatment. The researchers reported the home-based treatment was generally acceptable and safe.

Abstract

Transcranial direct current stimulation (tDCS) has been proposed as a new treatment in major depressive disorder (MDD). This is a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured using the Hamilton Depression Rating Scale (mean = 19.07 ± 2.73). A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95% confidence interval = 0.51-4.01, P = 0.012). There were no differences in discontinuation rates. In summary, a 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety. ClinicalTrials.gov registration: NCT05202119.

Topics

Attention Deficit Hyperactivity Disorder Electroconvulsive Therapy Studies Transcranial Magnetic Stimulation Studies

Categories

Life Sciences Neurology Neuroscience

Tags

Alternative medicine Clinical endpoint Cognition Depression (economics) Developmental psychology Discontinuation Dorsolateral prefrontal cortex Economics Internal medicine Macroeconomics Major depressive disorder Medicine Pathology Physical therapy Placebo Prefrontal cortex Psychiatry Psychology Randomized controlled trial Rating scale Stimulation Transcranial direct-current stimulation

Conditions & symptoms

Depression Lack of energy or motivation Sadness or low mood