In the Journals

Feasibility trial shows brain stimulation safe, well-tolerated in anorexia nervosa

Treatment with repetitive transcranial magnetic stimulation was feasible and acceptable to adults with severe and enduring anorexia nervosa, according to preliminary findings published in BMJ Open.

Noninvasive neuromodulation is a promising emerging treatment for [severe and enduring anorexia nervosa], in particular repetitive transcranial magnetic stimulation (rTMS),” Bethan Dalton, PhD student, section of eating disorders, department of psychological medicine at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, and colleagues wrote. “To date, no sham-controlled randomized controlled trial of rTMS in [severe and enduring anorexia nervosa] has been conducted.”

Researchers conducted a feasibility study of a double-blind randomized controlled trial of rTMS in community-dwelling adults with anorexia nervosa who had an illness duration of 3 or more years and completed at least one previous treatment.

Participants received 20 sessions of real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex administered over 4 weeks along with treatment-as-usual. At baseline, posttreatment and follow-up (0 months, 1 month and 4 months post-randomization), the investigators assessed recruitment, attendance and retention rates, as well as BMI, eating disorder symptoms, mood, quality of life and rTMS safety and tolerability.

Of 34 participants randomly allocated to real or sham rTMS, one participant per group withdrew before the intervention and two participants receiving sham did not complete therapy. The retention rate was 93.75%.

The results revealed that rTMS was safe and well-tolerated. All between-group effect sizes from baseline to follow-up favored rTMS over sham. Between-group effect sizes of change scores were small for BMI (Cohen d = 0.2; 95% CI, 0.49 to 0.9) and eating disorder symptoms (Cohen d = 0.1; 95% CI, 0.6 to 0.79), medium for quality of life and moderate to large for mood outcomes (Cohen d = 0.61 to 1). Notably, 71% of those who completed the sham intervention accepted the offer of having real rTMS treatment.

“[R]TMS was safe, well-tolerated and considered to be an acceptable treatment by participants. These various findings suggest that it is feasible to conduct a future larger-scale therapeutic [randomized controlled trial] with a sham-controlled design to establish the therapeutic efficacy of rTMS in [severe and enduring anorexia nervosa],” Dalton and colleagues wrote. “Building on the present study, a large-scale multicenter [randomized controlled trial] of real vs. sham rTMS as an adjunct to [treatment-as-usual] with a similar design should be considered. Such a trial should include a longer follow-up period (eg, 6 months and 12 months) to assess the persistence or otherwise of rTMS effects. This is also of importance given that neuroplastic changes develop over time.” – by Savannah Demko

Disclosures: Dalton reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Treatment with repetitive transcranial magnetic stimulation was feasible and acceptable to adults with severe and enduring anorexia nervosa, according to preliminary findings published in BMJ Open.

Noninvasive neuromodulation is a promising emerging treatment for [severe and enduring anorexia nervosa], in particular repetitive transcranial magnetic stimulation (rTMS),” Bethan Dalton, PhD student, section of eating disorders, department of psychological medicine at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, and colleagues wrote. “To date, no sham-controlled randomized controlled trial of rTMS in [severe and enduring anorexia nervosa] has been conducted.”

Researchers conducted a feasibility study of a double-blind randomized controlled trial of rTMS in community-dwelling adults with anorexia nervosa who had an illness duration of 3 or more years and completed at least one previous treatment.

Participants received 20 sessions of real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex administered over 4 weeks along with treatment-as-usual. At baseline, posttreatment and follow-up (0 months, 1 month and 4 months post-randomization), the investigators assessed recruitment, attendance and retention rates, as well as BMI, eating disorder symptoms, mood, quality of life and rTMS safety and tolerability.

Of 34 participants randomly allocated to real or sham rTMS, one participant per group withdrew before the intervention and two participants receiving sham did not complete therapy. The retention rate was 93.75%.

The results revealed that rTMS was safe and well-tolerated. All between-group effect sizes from baseline to follow-up favored rTMS over sham. Between-group effect sizes of change scores were small for BMI (Cohen d = 0.2; 95% CI, 0.49 to 0.9) and eating disorder symptoms (Cohen d = 0.1; 95% CI, 0.6 to 0.79), medium for quality of life and moderate to large for mood outcomes (Cohen d = 0.61 to 1). Notably, 71% of those who completed the sham intervention accepted the offer of having real rTMS treatment.

“[R]TMS was safe, well-tolerated and considered to be an acceptable treatment by participants. These various findings suggest that it is feasible to conduct a future larger-scale therapeutic [randomized controlled trial] with a sham-controlled design to establish the therapeutic efficacy of rTMS in [severe and enduring anorexia nervosa],” Dalton and colleagues wrote. “Building on the present study, a large-scale multicenter [randomized controlled trial] of real vs. sham rTMS as an adjunct to [treatment-as-usual] with a similar design should be considered. Such a trial should include a longer follow-up period (eg, 6 months and 12 months) to assess the persistence or otherwise of rTMS effects. This is also of importance given that neuroplastic changes develop over time.” – by Savannah Demko

Disclosures: Dalton reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.