Randomised controlled trial of neurostimulation for symptoms of anorexia nervosa (TRENA study): study protocol

Abstract

Background Anorexia nervosa (AN) has amongst the highest mortality rates and the highest treatment costs of any psychiatric disorder. Recently, interest in non-invasive brain stimulation as a novel treatment for AN has grown. These include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Methods This double-blind, randomised sham-controlled trial will compare the relative acceptability and efficacy of tDCS and rTMS in people with AN. 70 participants will be randomised to active or sham tDCS, or active or sham rTMS treatment (2:1:2:1 ratio) over an 8-week treatment period. Participants will receive treatment as usual across the study duration. The primary outcomes are change on the Eating Disorder Examination Questionnaire and treatment acceptability. Secondary outcomes will include change in weight, cognition, mood, interpersonal functioning, and quality of life. Following the 8-week assessment, all participants will have the option of receiving an additional 12 weeks of at-home tDCS. A follow-up assessment will be conducted at 20 weeks post treatment. Discussion Research into non-invasive brain stimulation as treatments for AN has potential to improve clinical outcomes for patients by comparing the relative efficacy and acceptability of both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS) results from this study will provide important information for informing future larger clinical trials of these treatments for AN. Trial registration ClinicalTrials.gov Identifier: NCT05788042.

The efficacy of transcranial direct current stimulation in the treatment of anorexia nervosa: a randomized double-blind clinical trial

“…In our project, we formulated a hypothesis regarding the effectiveness of tDCS in the treatment of anorexia, measured as a reduction of the severity of eating disorder symptoms. At the time of writing this article, there are also four published research papers ( 14 , 16 – 18 ) and two study protocols ( 19 , 20 ) assessing the effectiveness of such therapy in AN, which encompass diverse approaches and outcomes. As of now, only one double-blind randomized controlled trial ( 17 ) has delved into the therapeutic possibilities of tDCS for AN.…”