Trial Outcomes & Findings for Clinical and Cost Effectiveness of Alpha-Stim AID CES (NCT NCT02901080)

Last Updated: 2021-07-22

Results Overview

The primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for participants with a primary working diagnosis of generalised anxiety disorder (GAD), as defined by the NHS IAPT service in terms of reliable improvement (at least a 5 point improvement on the GAD-7),or recovery (total score of less than 7 and at least a 5 point improvement on the GAD-7), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

24 weeks

Results posted on

2021-07-22

Participant Flow

All 161 participants who enrolled in the study began the treatment.

Participant milestones

Participant milestones
Measure	Cranial Electrotherapy Stimulation Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks. Pregnancy test: - Pregnancy test (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)
Overall Study STARTED	161
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Cost Effectiveness of Alpha-Stim AID CES

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cranial Electrotherapy Stimulation n=161 Participants Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire 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 (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee
Age, Continuous	38.00 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	153 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United Kingdom	161 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Number of participants achieving at least 50% improvement on the GAD-7 from CES treatment.

Outcome measures

Outcome measures
Measure	Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes n=161 Participants Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire 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 (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee
Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7	102 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Cost savings per patient of treatment with Alpha-Stim versus treatment as usual

The secondary objective of this study is to evaluate the cost effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of health and social care service cost, and patient cost, from baseline to week 24, following previous treatment with low intensity psychological therapy intervention. The health and social care service cost and patient cost will be aggregated to determine the QALY (quality adjusted life year) value of the intervention. QALYs are used by the National Institute for Clinical Excellence (NICE) in the United Kingdom to determine the cost effectiveness of a treatment, and to determine whether it should be made available free at point of use in the National Health Service (NHS).

Outcome measures

Outcome measures
Measure	Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes n=161 Participants Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire 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 (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee
Cost Effectiveness in Generalised Anxiety Disorder Compared to Current Treatment Approaches	540 Pound sterling Interval 327.0 to 648.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Number of participants with at least reliable improvement in depression symptoms

The third objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for depression in participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of reliable improvement (a 6 point reduction in scores on the PHQ-9) or recovery (a score of 9 or less and at least a 6 point drop on the PHQ-9), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.

Outcome measures

Outcome measures
Measure	Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes n=161 Participants Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire 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 (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee
Clinical Effectiveness in Depression as Measured by Reduction of at Least 6 Points in Scores on the Personal Health Questionnaire (PHQ-9)	80 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Number of participants experiencing at least reliable improvement in sleep

The fourth objective of the tertiary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for insomnia in participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of reliable improvement (at least a 50% reduction in scores on the AIS), and recovery (a score of less than 4 and a reduction of at least 50% in AIS score), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.

Outcome measures

Outcome measures
Measure	Cranial Electrotherapy Stimulation at 100 uA for 60 Minutes n=161 Participants Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire 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 (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, wee
Clinical Effectiveness in Insomnia as Measured by at Least a 50% Reduction in Score on the Athens Insomnia Scale (AIS)	48 Participants

Adverse Events

Cranial Electrotherapy Stimulation

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cranial Electrotherapy Stimulation n=161 participants at risk Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire Alpha Stim AID cranial electrotherapy stimulation: - 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for 6 to 12 weeks. Pregnancy test: - Pregnancy test (day 1) Anxiety questionnaire: - GAD-7 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life questionnaire: - EQ-5D-5L (day 1, week 4, week 6, week 8, week 12 and week 24) Work and social questionnaire: - WASA (day 1, week 4, week 6, week 8, week 12 and week 24) Sleep questionnaire: - Athens (day 1, week 4, week 6, week 8, week 12 and week 24) Depression questionnaire: - PHQ-9 (day 1, week 4, week 6, week 8, week 12 and week 24) Quality of life and financial questionnaire: - CSRI (day 1, week 12 and week 24)
Product Issues Headache and insomnia	1.2% 2/161 • Number of events 2 • 24 weeks
Gastrointestinal disorders Nausea	0.62% 1/161 • Number of events 1 • 24 weeks
General disorders Strange feeling after use	0.62% 1/161 • Number of events 1 • 24 weeks

Additional Information

Science and Education Director

Electromedical Products International, Inc.

Phone: 8174583295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place