Abstract
Background and aims: Repetitive transcranial magnetic stimulation (rTMS) applied with focal coils in Alzheimer’s disease (AD) revealed positive effects on cognition. The H-coil is able to depolarize deeper and wider neuronal structures compared with focal coils. Our aim was to evaluate feasibility, safety and efficacy of excitatory rTMS with H-coil in AD.
Methods: 30 AD subjects (age 70.21±8.66; MMSE 17.31±5.77), randomized in real and sham group, under-went 12 rTMS sessions within 4 weeks, then a 4-week maintenance (1/week), over the fronto- parieto-temporal lobes (10Hz; 120%RMT). Neuropsychological assessment (Alzheimer’s Disease Assessment Scale cognitive - ADAS-cog, Mini-Mental State Examination-MMSE, Beck Depression Inventory-II, Clinical Global Impression-Improvement, a word recognition task) were performed at baseline, 4 weeks from start of treatment (4w), end of treatment (8w), follow-up (8 weeks after 8w).
Results: No serious side effects were reported and no patient dropped due to side effects. Four subjects were excluded from the analyses (1 acute myocardial infarction in the sham group, 1 misdiagnosis, 2 missing data). Comparing percent ADAS-cog change at 4w with a null hypothesis of 0 change, only the real group significantly improved (-7.22±10.49 %, p=0.046). To achieve 3-4 points group difference change ADAS-cog with 80% power, we calculated a sample size 16-22 per arm.
Conclusion: Our preliminary findings suggest that rTMS with H-coil is a safe and feasible procedure in AD, with good patients’ adherence. Our neuropsychological data will be used to plan phase II trials on a larger sample. Future studies should explore earlier disease phases and the com-bination with cognitive training
Methods: 30 AD subjects (age 70.21±8.66; MMSE 17.31±5.77), randomized in real and sham group, under-went 12 rTMS sessions within 4 weeks, then a 4-week maintenance (1/week), over the fronto- parieto-temporal lobes (10Hz; 120%RMT). Neuropsychological assessment (Alzheimer’s Disease Assessment Scale cognitive - ADAS-cog, Mini-Mental State Examination-MMSE, Beck Depression Inventory-II, Clinical Global Impression-Improvement, a word recognition task) were performed at baseline, 4 weeks from start of treatment (4w), end of treatment (8w), follow-up (8 weeks after 8w).
Results: No serious side effects were reported and no patient dropped due to side effects. Four subjects were excluded from the analyses (1 acute myocardial infarction in the sham group, 1 misdiagnosis, 2 missing data). Comparing percent ADAS-cog change at 4w with a null hypothesis of 0 change, only the real group significantly improved (-7.22±10.49 %, p=0.046). To achieve 3-4 points group difference change ADAS-cog with 80% power, we calculated a sample size 16-22 per arm.
Conclusion: Our preliminary findings suggest that rTMS with H-coil is a safe and feasible procedure in AD, with good patients’ adherence. Our neuropsychological data will be used to plan phase II trials on a larger sample. Future studies should explore earlier disease phases and the com-bination with cognitive training
| Original language | English |
|---|---|
| Pages (from-to) | 277-277 |
| Journal | European Journal of Neurology |
| Volume | 22 |
| Issue number | S1 |
| DOIs | |
| State | Published - 2015 |