Skip to main content
. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
Outcomes Primary: pain VAS
When taken: postintervention
Secondary: AEs
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."
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