Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial

Hodaj, Hasan; Payen, Jean‐François; Mick, G.; Vercueil, Laurent; Hodaj, Enkelejda; Dumolard, Anne; Noëlle, Bénédicte; Delon‐Martin, Chantal; Lefaucheur, Jean‐Pascal

doi:10.1016/j.brs.2022.02.012

Cited by 11 publications

(8 citation statements)

References 91 publications

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“…To find studies comparable to ours, we carried out a literature search to find RCTs with at least four weeks of treatment and at least 12 weeks of follow-up. Four RCTs were found where participants received four weeks of anodal tDCS at M1 and were followed up for between 12 and 16 weeks ( 32 , 35 , 57 , 58 ). Sample sizes were small, N = 13, 37, 19 and 36 respectively.…”

Section: Discussionmentioning

confidence: 99%

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Transcranial direct current stimulation for chronic headaches, a randomized, controlled trial

Hervik,

Vika,

Stub

2024

Front. Pain Res.

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Background and objectivesChronic headaches are a frequent cause of pain and disability. The purpose of this randomized trial was to examine whether transcranial direct current stimulation (tDCS) applied to the primary motor cortex, reduces pain and increases daily function in individuals suffering from primary chronic headache.Materials and methodsA prospective, randomized, controlled trial, where participants and assessors were blinded, investigated the effect of active tDCS vs. sham tDCS in chronic headache sufferers. Forty subjects between 18 and 70 years of age, with a diagnosis of primary chronic headache were randomized to either active tDCS or sham tDCS treatment groups. All patients received eight treatments over four consecutive weeks. Anodal stimulation (2 mA) directed at the primary motor cortex (M1), was applied for 30 min in the active tDCS group. Participants in the sham tDCS group received 30 s of M1 stimulation at the start and end of the 30-minute procedure; for the remaining 29 min, they did not receive any stimulation. Outcome measures based on data collected at baseline, after eight treatments and three months later included changes in daily function, pain levels, and medication.ResultsSignificant improvements in both daily function and pain levels were observed in participants treated with active tDCS, compared to sham tDCS. Effects lasted up to 12 weeks post-treatment. Medication use remained unchanged in both groups throughout the trial with no serious adverse effects reported.ConclusionThese results suggest that tDCS has the potential to improve daily function and reduce pain in patients suffering from chronic headaches. Larger randomized, controlled trials are needed to confirm these findings.Trial registrationThe study was approved by the local ethics committee (2018/2514) and by the Norwegian Centre for Research Data (54483).

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Section: Discussionmentioning

confidence: 99%

“…All four trials reported a significant reduction in pain intensity lasting up to the follow-up points. Three of the trials ( 32 , 35 , 58 ) had 12-week follow-up points. DaSilva ( 33 ) reported a significant reduction in pain intensity at a 16-week follow-up point.…”

Section: Discussionmentioning

confidence: 99%

Transcranial direct current stimulation for chronic headaches, a randomized, controlled trial

Hervik,

Vika,

Stub

2024

Front. Pain Res.

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“…This allowed us to provide detailed descriptions of overall AE reports as well as condition-differences using Frequentist and Bayesian statistics, including spatio-temporal AE aspects and blinding success. To our knowledge, this combination of factors goes far beyond what has previously been carried out in the tsDCS literature: out of 76 human tsDCS studies, only nine [24][25][26][27][28][29][30][31][32] employed structured questionnaires, with only three of these statistically comparing effects under active and sham conditions [25,28,29] and none investigating spatio-temporal aspects. Our study thus provides a starting point for a systematic and comprehensive assessment of tsDCS AEs, and we believe that the tsDCS community might benefit from a standardized and psychometrically evaluated questionnaire.…”

Section: Adverse Effects (Aes) Of Tsdcsmentioning

confidence: 99%

Assessing adverse effects and unspecific effects of transcutaneous spinal direct current stimulation (tsDCS)

Zhao,

Horn,

Freund

et al. 2023

Preprint

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BackgroundTranscutaneous spinal direct current stimulation (tsDCS) is a relatively recent method for non-invasively modulating neuronal activity in the human spinal cord. Despite its growing prominence, comprehensive studies addressing its potential adverse effects (AEs) and unspecific effects (UEs) are lacking.ObjectiveIn this study, we conducted a systematic investigation into the potential AEs and UEs of tsDCS in healthy volunteers.MethodsWe used a randomized double-blind within-participant design, employing anodal, cathodal and sham tsDCS of the thoracolumbar spinal cord. Our approach involved a newly-developed structured questionnaire (to assess subjectively-reported AEs) in combination with tsDCS-concurrent recording of skin conductance, cardiac and respiratory activity (to assess UEs in bodily state).ResultsThe most frequently participant-reported AEs were sensations of burning, tingling, and itching, although they were largely described as mild; skin redness (experimenter-reported) occurred even more frequently. Importantly, when comparing AEs between active and sham tsDCS via frequentist and Bayesian analysis approaches, the results were largely in favour of no difference between conditions (with the exception of skin redness). A similar picture emerged for most UE metrics, suggesting that tsDCS does not induce changes in bodily state, at least as measured by our autonomic nervous system metrics.ConclusionWe believe that the strategy employed here could serve as a starting point for a systematic AE and UE assessment in clinical populations, longitudinal designs and when stimulating different spinal sites. Taken together, our results contribute to assessing the tolerability, safety and specificity of tsDCS, in order to further the investigation of spinal cord function in health and disease.

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“…This also made it possible to avoid subjecting patients suffering from drug-resistant pain for many years to a placebo. Although the placement of the anode tDCS was centered on the motor cortex, the size of the electrodes and the standard motor-prefrontal montages entail a current distribution covering a region much more extended than the focalized figure-of-eight rTMS coil, and could render the comparison hazardous [47]. New highdefinition tDCS montages could permit more focalized current distribution around the motor cortex, but their use in neuropathic pain remains anecdotal [48].…”

Section: Limitationsmentioning

confidence: 99%

Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain

Obadia

Hodaj

et al. 2023

Neurotherapeutics

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While high-frequency transcranial magnetic stimulation (HF-rTMS) is now included in the armamentarium to treat chronic neuropathic pain (NP), direct-current anodal stimulation (a-tDCS) to the same cortical targets may represent a valuable alternative in terms of feasibility and cost. Here we performed a head-to-head, randomized, single-blinded, cross-over comparison of HF-rTMS versus a-tDCS over the motor cortex in 56 patients with drug-resistant NP, who received 5 daily sessions of each procedure, with a washout of at least 4 weeks. Daily scores of pain, sleep, and fatigue were obtained during 5 consecutive weeks, and functional magnetic resonance imaging (fMRI) to a motor task was performed in a subgroup of 31 patients. The percentage of responders, defined by a reduction in pain scores of > 2 SDs from pre-stimulus levels, was similar to both techniques (42.0% vs. 42.3%), while the magnitude of "best pain relief" was significantly skewed towards rTMS. Mean pain ratings in responders decreased by 32.6% (rTMS) and 29.6% (tDCS), with half of them being sensitive to only one technique. Movement-related fMRI showed significant activations in motor and premotor areas, which did not change after 5 days of stimulation, and did not discriminate responders from non-responders. Both HF-rTMS and a-tDCS showed efficacy at 1 month in drug-resistant NP, with magnitude of relief slightly favoring rTMS. Since a significant proportion of patients responded to one procedure only, both modalities should be tested before declaring a patient as unresponsive.

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Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial

Cited by 11 publications

References 91 publications

Transcranial direct current stimulation for chronic headaches, a randomized, controlled trial

Transcranial direct current stimulation for chronic headaches, a randomized, controlled trial

Assessing adverse effects and unspecific effects of transcutaneous spinal direct current stimulation (tsDCS)

Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain

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