Methods | Cross‐over RCT | |
Participants | Country of study: Germany Setting: laboratory Condition: trigeminal neuralgia Prior management details: stable medication for 6 months prior to study, no invasive procedures prior to study n = 17 Age range: 32‐72 years Duration of symptoms: range 2‐27 years, mean 13 Gender distribution: 7 M, 10 F |
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Interventions | Stimulation type: tDCS Stimulation parameters: intensity 1 mA, 40 cm2 electrodes, duration 20 min Stimulation location: anode ‐ M1 contralateral to painful side, cathode supraorbital contralateral to anode Number of treatments: daily, self‐administered for 14 days Control type: sham tDCS |
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Outcomes | Primary: pain VAS When taken: postintervention Secondary: AEs |
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Notes | Study authors' COI statement: "Tim Hagenacker has received research support from Astellas and CSL Behring. Vera Bude, Steffen Naegel have nothing to disclose. Dagny Holle has received research support from Grünental and Allergan. Mark Obermann has received scientific support and/or honoraria from Biogen Idec, Novartis, Sanofi‐Aventis, Genzyme, Pfizer, Teva. He received research grants from Allergan, Electrocore, and the German Ministry for Education and Research (BMBF). Hans‐Christoph Diener has received honoraria for participation in clinical trials, contribution to advisory boards or lectures from Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin Chemie, Coherex Medical, CoLucid, Böhringer Ingelheim, Bristol‐Myers Squibb, GlaxoSmithKline, Grünenthal, Janssen‐Cilag, Lilly, La Roche, 3M Medica, Minster, MSD, Novartis, Johnson & Johnson, Pierre Fabre, Pfizer, Schaper and Brümmer, SanofiAventis, and Weber & Weber; received research support from Allergan, Almirall, AstraZeneca, Bayer, Galaxo‐Smith‐Kline, Janssen‐Cilag, and Pfizer. Sources of support: "Headache research at the Department of Neurology in Essen is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF), and the European Union." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: method of randomisation not reported |
Adequate blinding of participants? | Unclear risk | Comment: method of blinding not clearly stated |
Adequate blinding of assessors? | Unclear risk | Comment: method of blinding not clearly stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 7/17 participants discontinued trial. Details of when not clear. Per‐protocol analysis |
Selective reporting (reporting bias) | Low risk | Comment: all key outcomes reported |
Free from carry‐over effects? | Unclear risk | No formal assessment of baseline equivalence reported |
Study Size | High risk | Comment: n = 17, 10 after attrition |
Study duration | High risk | Comment: only immediate postintervention follow‐up |
Other bias | Low risk | Comment: no other bias detected |