161
Participants
Start Date
August 11, 2016
Primary Completion Date
October 31, 2017
Study Completion Date
December 31, 2017
Alpha Stim AID cranial electrotherapy stimulation
\- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.
Pregnancy test
\- Pregnancy test x 1 (day 1)
Anxiety questionnaire
\- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life questionnaire
\- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Work and social questionnaire
\- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Sleep questionnaire
\- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Depression questionnaire
\- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life and financial questionnaire
\- CSRI questionnaire x 3 (day 1, week 12 and week 24)
Leicestershire and Rutland Improving Access to Psychological Therapies (IAPT) Service, Nottingham
Lead Sponsor
Electromedical Products International, Inc.
INDUSTRY