No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial

Abstract

Background Transcranial direct current stimulation was suggested to provide beneficial effects in chronic migraine, a condition often associated with medication overuse for which no long-term therapy is available. Methods We conducted a randomised controlled trial to assess long-term efficacy of transcranial direct current stimulation. Adults diagnosed with chronic migraine and medication overuse were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham transcranial direct current stimulation daily for five consecutive days, along with standardised drug withdrawal protocol. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period. Results We randomly allocated 135 patients to anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation. At 6 and 12 months, the percentage of reduction of days of headache and number of analgesics per month ranged between 48.5% and 64.7%, without differences between transcranial direct current stimulation (cathodal, anodal, or the results obtained from the two arms of treatment, anodal plus cathodal) and sham. Catastrophising attitude significantly reduced at 12 months in all groups. There was no difference for the other secondary outcomes. Conclusions Transcranial direct current stimulation did not influence the short and long-term course of chronic migraine with medication overuse after acute drug withdrawal. Behavioral and educational measures and support for patients’ pain management could provide long-term improvement and low relapse rate. Trial registration number NCT04228809

Analgesic Effect of Noninvasive Brain Stimulation for Neuropathic Pain Patients: A Systematic Review

“…Dalla Volta et al have observed that 3 months after the last tDCS stimulation, the patients with drug-resistant migrainous could still obtain a reduction of 50% of pain scores [84]. However, some reports have shown that there is no long-term analgesic effect of tDCS on chronic migraine [85] or lung cancer pain [86], while the long-term effect of rTMS on pain relief has been shown in a 6-month study of rTMS treatment in patients with facial pain [42] or with nerve injury induced NP [35]. We have also noticed that the active rTMS could significantly reduce pain intensity with the time course of 25 weeks [79] or even 2.8 years [21].…”

Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine Treatment—A Narrative Review

“…The difference was very large in both groups, with 12.5 days/month for the M1 versus 9.5 for the S1 group compared to the sham group. Another recent study compared anodal, cathodal, and sham tDCS over the right M1, used daily for the 5 days of withdrawal treatment for patients with chronic migraine associated with medication overuse [ 53 ]. There was no significant difference in the number of migraine days per month 12 months later.…”

Is Allodynia a Determinant Factor in the Effectiveness of Transcranial Direct Current Stimulation in the Prophylaxis of Migraine?

“…A recent study conducted in a large chronic migraine population with or without medication overuse reported that M1 tDCS is not effective at 6‐ and 12‐month (50). The results of this study may have been discordant with our positive results, as they examined a more resistant group by including only those with resistance to two previous prophylaxis trials.…”