Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials

Zis, Panagiotis; Shafique, Faiza; Hadjivassiliou, Marios; Blackburn, Daniel; Venneri, Annalena; Iliodromiti, Stamatina; Mitsikostas, Dimos‐Dimitrios; Sarrigiannis, Ptolemaios G.

doi:10.1111/ner.12946

Cited by 57 publications

(39 citation statements)

References 32 publications

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“…rTMS is generally safe and its associated adverse effects well-tolerated. Serious adverse effects, such as seizure induction, are rare [30,31]. Seizure induction is associated with high-frequency sitmulation [32] and in this context it would be reasonable to assume that TBS protocols may be associated with greater rates of seizure (or other unidentified issues).…”

Section: Discussionmentioning

confidence: 99%

A pilot investigation of an intensive theta burst stimulation protocol for patients with treatment resistant depression

et al. 2020

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Introduction: Accelerated or intensive forms of repetitive transcranial magnetic stimulation (rTMS) are increasingly being explored for their potential to produce more efficient and rapid treatment benefits in major depressive disorder (MDD). However, accelerated or intensive protocols using standard forms of rTMS are still quite time-consuming to apply. Theta burst stimulation (TBS) is a novel form of magnetic stimulation with the potential to produce similar anti-depressant effects but in a much abbreviated period of time. The aim of this study was to investigate the comparative efficacy of an intensive TBS protocol compared to standard rTMS treatment. Methods: 74 outpatients (36 female, mean age 44.36 ± 12.1 years) with MDD received either intensive TBS (3 intermittent TBS treatments per day for 3 days in week 1, 3 treatments a day for 2 days in week 2, and 3 treatments in 1 day in week 3 and in week 4, or standard rTMS (5 daily sessions per week for 4 weeks). Patients were assessed weekly throughout the treatment course, and at 4 weeks after treatment end. Results: There were no significant differences in the degree of reduction in depressive symptoms, the rate of reduction in depressive symptoms, remission or response rates (response rates ¼ 27.8% for intensive group, 26.3% for the standard group, p > 0.05 for all analyses) between the intensive TBS and standard rTMS treatment groups. However, the overall response and remission rates were limited in both groups. There was no difference in rates of side effects, no serious adverse events and no alterations in cognitive performance. Conclusion: Intensively applied TBS appears to have similar efficacy to standard rTMS when these were applied as delivered in this study but does not produce more rapid clinical benefits. The overall response rates in both groups in this study were limited, most likely by the total doses provided in both study arms. Clinical trials registration: Australian New Zealand Clinical Trials Registry: ACTRN12616000443493.

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Section: Discussionmentioning

confidence: 99%

A pilot investigation of an intensive theta burst stimulation protocol for patients with treatment resistant depression

et al. 2020

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“…Repetitive transcranial magnetic stimulation (rTMS) is a safe and well-tolerated intervention that has been used for the treatment of many forms of neuropathic pain [82,83]. The use of rTMS of the motor cortex for the treatment of CPSP has only been studied in small studies (fewer than 25 subjects in each study) with contradictory results.…”

Section: Magnetic Stimulationmentioning

confidence: 99%

Prevalence and Management Challenges in Central Post-Stroke Neuropathic Pain: A Systematic Review and Meta-analysis

et al. 2020

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Introduction: Central post-stroke pain (CPSP) is defined as the neuropathic pain that arises either acutely or in the chronic phase of a cerebrovascular event and is a result of central lesions of the somatosensory tract. The aim of this systematic review and meta-analysis was to establish the prevalence of CPSP, to describe its characteristics, and to discuss the associated management challenges. Methods: After a systematic Medline search, we identified 69 papers eligible to be included. Results: The pooled prevalence of CPSP in patients with stroke at any location was 11% (95% CI 7-18%), which can increase to more than 50% in the subgroups of patients with medullary or thalamic strokes. CPSP onset coincides with stroke occurrence in 26% of patients (95% CI 18-35%); CPSP manifests within a month since symptom onset in 31% of patients (95% CI 22-42%), and occurs between the first month and the first year in 41% of patients (95% CI 33.9-49.0%). CPSP develops more than 12 months after stroke onset in 5% of patients (95% CI 3-8%). Conclusions: Clinicians should look for any evidence of central neuropathic pain for at least 12 months after stroke. Both pharmacological and non-pharmacological interventions can be used for the management of CPSP. Lamotrigine has the strongest evidence (Level II of evidence, derived from small randomized controlled trials) for being effective in the management of CPSP. Future research should focus on well-designed trials of pharmacological and non-pharmacological interventions aiming to relief CPSP, which is a very common but often neglected pain syndrome.

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“…Considering the very large number of subjects who have participated in TMS studies since 1998 and the small number of seizures, the risk of TMS inducing seizures is considered to be very low (4). A systematic review that included 93 sham-controlled RCTs (15), reported that headache or discomfort at stimulation site was the most commonly reported in both active treatment and sham group (19.7% vs 10.1% respectively). The second most reported adverse effects were dizziness accounting about 1.8% in sham group and 2.8% in active TMS group.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation for Preventive Treatment of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial (Magnet-EM).

Safiai

Amir

Basri

et al. 2020

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Background: This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine among migraine subjects. Methods: Subjects age 18 to 60 years will undergo a baseline evaluation to establish the diagnosis of migraine based on International Classification of Headache Disorder 3rd Edition (ICHD-3). Those who fulfil the ICHD-3 criteria for episodic migraine and compliant to the headache diary during a month run-in period will be enrolled. A total of 76 subjects will be randomised to receive either transcranial magnetic stimulation or sham stimulation for 5 sessions within 2 weeks duration. Follow-up sessions will be conducted monthly for three consecutive months. Prior to treatment, subjects will be required to fill up questionnaires and undergo few procedures such as electroencephalography, transcranial doppler ultrasound and biochemical analysis for serum serotonin, serum calcitonin-gene related peptide and serum beta-endorphin. These procedures will be repeated at month 3 after receiving last treatment. The primary outcome measure of this study is the difference in mean monthly migraine days at baseline and at month 1, 2 and 3 after treatment sessions. Discussion: Following evidence from previous studies showing restoration of dorsolateral prefrontal cortex (DLPFC) activation to almost normal level, the rTMS intervention will target left DLPFC in this study. An intermediate duration of treatment sessions is selected for this study. It is set to five treatment sessions given within 2 weeks duration. Trial registration: NCT03556722. Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM) was registered on 27th April 2018. https://clinicaltrials.gov/ct2/show/NCT03556722.

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Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials

Cited by 57 publications

References 32 publications

A pilot investigation of an intensive theta burst stimulation protocol for patients with treatment resistant depression

A pilot investigation of an intensive theta burst stimulation protocol for patients with treatment resistant depression

Prevalence and Management Challenges in Central Post-Stroke Neuropathic Pain: A Systematic Review and Meta-analysis

Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation for Preventive Treatment of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial (Magnet-EM).

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