Combined Use of Transcranial Magnetic Stimulation and Pramipexole in the Treatment of Aberrant Motor Behavior in Elderly People with Dementia: A Randomized Pilot Study

Abstract Background This study aims to evaluate the efficacy of combined treatment with repetitive transcranial magnetic stimulation (rTMS) associated with pramipexole in neuromodulation and control of aberrant motor behavior (AMB) in elderly patients with dementia, as well as to study the behavior of serum irisin – a myokine associated with motor activity. Method Eight elderly patients with Alzheimer’s disease dementia were allocated by randomization to an active or placebo group. The active group received high-frequency rTMS and 0.25 mg of pramipexole for five consecutive days. The placebo group received sham stimulation and an inert pill for same time. After a 4-week washout period, the patients were switched between groups. Neuropsychiatric symptom questionnaires, global cognitive assessments, and blood samples for serum irisin measurement were collected. Data were analyzed using the Wilcoxon and Mann-Whitney tests, and exploratory analysis was performed using bootstrap. Results There was no treatment efficacy for the AMB subscores on Neuropsychiatry Inventory (NPI). Cognitive measures in severe Mini-Mental Status Examination scores showed a signal of improvement in test group, however these findings should be considered preliminary ( p = 0.034; CI95% 0,0 ; 9,0). A stability of serum irisin was also observed in the test group ( p = 1,000, CI95% -1359; 643) along with an absolute increase in serum irisin in placebo group ( p = 0.039, CI95% -322 ; 3948). Conclusion The proposed intervention did not improve AMB control scores using validated tools, but was associated to preliminary findings of improvement in global cognition and reduced serum irisin levels in the patients evaluated. Trial Registration Approval ID RBR-9zmnvn6 retrospectively registered on Brazilian Registry of Clinical Trials (ReBEC).