Original Title: Estimulación magnética transcraneal repetitiva para trastornos psiquiátricos y neurológicos

Authors' objectives: • To assess the effectiveness and safety of rTMS in a range of psychiatric and neurological disorders. • To assess the cost-effectiveness of rTMS in these disorders. • To identify the ethical, legal, organisational, social and environmental (ELOSA) issues related to the technology.

Authors' results and conclusions: RESULTS --- EFFECTIVENESS/SAFETY We included 21 MAs (3 in OCD, 2 in PTSD, 2 in auditory hallucinations, 4 in Parkinson's disease, 2 in childhood CP, 3 in Alzheimer's disease, 4 in chronic pain, and 1 in tinnitus; none on FMT) and 45 RCTs (4 in OCD, 4 in PTSD, 3 in auditory hallucinations, 4 in Parkinson's disease, 2 in childhood CP, 3 in FMT, 12 in Alzheimer's disease, 8 in chronic pain, and 5 in tinnitus). For FMT, only 3 small RCTs with mixed results representing very weak evidence were identified. For the other conditions, the table shows a summary of the results on symptom reduction, based on the included MAs. In all of them, at least one of the protocols evaluated has produced statistically significant effects in the reduction of symptoms. In the case of auditory hallucinations, the most evaluated protocol (LF-CTP-l) does not seem to produce a relevant clinical effect, while ERTc could produce a significant effect, although it has only been evaluated in two small studies. Strong effects were obtained in OCD, PTSD, spinal cord injury pain and migraine/headache, and small-moderate in the rest of the conditions. However, the quality of this evidence is low or very low for all cases; it was only considered of moderate quality for fine motor function in the case of childhood CP. Quality of life was evaluated in few reviews, and significant results were only obtained in this last condition and in tinnitus, with an equally low quality of evidence. The safety results have been assessed as of moderate quality. The technique can produce a variety of adverse effects (e.g., headache or pain in the application area, dizziness, nausea, fatigue and others) but in no case have they been serious and have been resolved without complications. In most of the protocols evaluated, the dropout rate has not been significantly different from that of sham stimulation. COST-EFFECTIVENESS Only two EEs performed outside Spain were identified, one in patients with obsessive-compulsive disorder and another in patients with treatment-refractory schizophrenia. Given this low number of studies and their limited methodological quality, it is not possible to formulate conclusions on the cost-effectiveness of rTMS. ELOSA ASPECTS Few studies have been found on the ethical, legal, organizational, social and environmental aspects of rTMS. Only two observational studies with small samples have analyzed the acceptability of rTMS for use by people with mild cognitive impairment or stroke affecting the upper limbs. These show that rTMS is generally well accepted by these patients. The implementation of rTMS requires the creation of standardized protocols to guarantee its safety and effectiveness. These protocols must be specific to each specific indication for use. In addition, it requires a multidisciplinary team that receives adequate ongoing training. On the other hand, the long-term effects are not known. There is uncertainty about the optimal duration of treatment and whether or not it should be prolonged with maintenance sessions in cases of chronic conditions. --- CONCLUSIONS --- • rTMS shows a good safety profile, with no serious adverse effects, although it can produce a variety of mild or moderate transient adverse effects, the most frequent being headache, pain or discomfort in the application area and dizziness. These effects are transient and easily resolvable, and they do not produce a relevant dropout rate so. • The evidence of effectiveness of rTMS is of low or very low quality for all the conditions evaluated. Most studies show unclear or high risk of bias and small sample sizes, and there is wide variability in the stimulation protocols applied, which minimizes the body of evidence for each of them, except in a few cases. Furthermore, the inconsistency of the results and/or the wide confidence interval add uncertainty to the pooled results. • The strongest short-term effects have been observed in obsessive-compulsive disorder and post-traumatic stress disorder, followed by pain due to spinal cord injury and migraine/headache. Therefore, these would be the conditions with the highest probability of showing a favorable risk/benefit balance. • Results that could be clinically relevant have also been observed in Parkinson's disease, infantile cerebral palsy and Alzheimer's disease. • The most widely evaluated protocol for the treatment of auditory hallucinations appears to produce a small effect of uncertain clinical relevance. Bilateral application of cTBS in the temporoparietal cortex has produced significant effects, but the evidence is based on two small studies. • In the case of tinnitus, the most evaluated protocol produced a small effect, of uncertain clinical relevance. Other protocols have obtained small-moderate effects on the severity of tinnitus or its impact on quality of life, but with a weak empirical basis. • It is not possible to establish conclusions about the cost-effectiveness of rTMS in Spain for the disorders analyzed.

Authors' methods: Four separate systematic reviews (SRs) of the literature were conducted for each of the objectives (for effectiveness, SRs and randomised controlled trials, RCTs, were searched separately). Medline, Embase, CINAHL, CDRS/CENTRAL databases were searched from January 2014 to June 2024. The effectiveness/safety SR focused on meta-analyses (MAs) and RCTs not included in them. The cost-effectiveness SR included full economic evaluations (EEs), and the ELOSA SR included any type of design. The populations to be included were: • Obsessive-compulsive disorder (OCD). • Post-traumatic stress disorder (PTSD). • Auditory hallucinations. • Parkinson's disease. • Cerebral palsy (CP). • Functional movement disorders (FMD). • Alzheimer's disease. • Chronic pain. • Tinnitus. Outcome measures included the reduction of the main symptoms of each disorder, quality of life and adverse effects. The methodological quality was assessed with the following instruments: AMSTAR-2 (for SR), RoB-2 tool (RCT), Drummond et al. criteria (EE), OSTEBA Critical Reading Sheet 3.0 (observational studies), CASPe instrument (qualitative studies) and SANRA (narrative reviews). The process of selecting the studies, assessing the risk of bias and extracting data was carried out by independent reviewers. For the synthesis of effectiveness and safety data, a narrative description of the results of the MAs and RCTs was performed, and in some cases, own MAs were performed. The synthesis of the SR of EE and ELOSA aspects was performed narratively.

Project Status: Completed

Year Published: 2025

URL for published report: https://sescs.es/en/rtms/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es