8
Participants
Start Date
July 31, 2024
Primary Completion Date
October 31, 2024
Study Completion Date
October 31, 2024
Sooma tDCS portable device - active stimulation
Treatment followed common tDCS protocol upon considering safety and tolerability, comprising five consecutive sessions in five days of 30-minute 2 mA tDCS. We utilized the Soterix Medical tDCS device (Soterix Medical, New York, NY, USA, Model 1x1 tDCS-CT) in the research lab and the Sooma Oy device (Sooma Depression Therapy Comfort, Helsinki, Finland) for patient self-administration.Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device.Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or. Due to the limited availability of the Sooma devices, participants were randomly allocated to either the Sooma or the Soterix device based on availability during their initial session. A current of 2 mA was applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode (reference electrode) was applied at the right dPLFC, F4.
Sooma tDCS portable device - sham stimulation
Sooma provided two of their portable tDCS devices for a brief period, including one customized sham device for effective blinding, distinguishable only by serial number and managed by an external data manager following the randomization sequence.To ensure blinding to the participant and their caregiver, at the beginning of the stimulation sessions, participants receiving both the active and sham stimulation would experience a ramp-up in current from 0 to 2 mA, and then the current would ramp down to 0 mA for participants receiving sham stimulation. Participants were told that they may experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of the stimulation session but that they may subside afterwards as they got used to it. In other words, participants would not be able to tell if diminishing of side effects were due to habituation (active tDCS) or ramping down of current (sham tDCS).
University of Hong Kong, Hong Kong
The University of Hong Kong
OTHER