Alpha-Stim AID and Alpha-Stim M

Abstract

5 Alpha-Stim units have been FDA cleared between 1983-1992. Whereas the 2 present Alpha-Stim merchandise are usually not particularly listed on the FDA web site, the corporate web site signifies that these are up to date variations. Alpha-Stim AID with earclips reportedly treats insomnia, nervousness, and despair. Alpha-Stim M has further “Sensible Probes” or self-adhesive “AS-Trodes” with the added intention to deal with acute or persistent ache. Linked to the stimulation machine, the consumer wears earclips for 20-60 minutes day by day after which 2-3 occasions weekly as signs enhance. The companion app permits the consumer to log in periods, journal the day, take assessments, discover Alpha-Stim FAQs, and to view progress analytics. Indications, warning and precautions, contraindications (no pacemakers or ICDs), and aspect/adversarial impacts are posted on a web site doc (see technical issues). Each affected person and supplier guides and assets can be found on the web site. Whereas there have been many medical trials and papers utilizing Alpha-Stim units over time, most research examined remedy for nervousness, despair, and/or ache.

Claimed Capabilities/Measurements

After 5 remedies, the web site claims that sleep time might enhance 43 minutes, sleep high quality is improved, and that it’s most popular over widespread sleep medication. It claims to work by making use of a patented, low amplitude waveform to the mind by way of earclip electrodes that stimulate cranial nerves and modulate cortical oscillations within the temporal lobe. Alpha-Stim AID with earclips reportedly treats insomnia, nervousness, and despair. Alpha-Stim M has further Sensible Probes or self-adhesive AS-Trodes to reportedly deal with acute or persistent ache over affected areas by modulating peripheral ache circuit signaling from the spinal twine. The web site gives a hyperlink for telehealth visits for these prescription merchandise.

Mechanism

N/A

Sensors

N/A

Technical Issues

https://alpha-stim.com/wp-content/uploads/2024/01/Alpha-Stim-HCP-Overview-Brochure-MKT-VG-004-Rev-B.pdf

Associated Publications and Abstracts

Quotation: Lande RG, Gragnani C. Efficacy of cranial electrical stimulation for the remedy of insomnia: a randomized pilot examine. Complement Ther Med. 2013 Feb;21(1):8-13. doi: 10.1016/j.ctim.2012.11.007. Epub 2012 Dec 21. PMID: 23374200.

DOI: https://doi.org/10.1016/j.ctim.2012.11.007

URL: https://www.sciencedirect.com/science/article/abs/pii/S096522991200163X?viapercent3Dihub

Business Assist: No

Validation examine: No

Comparability take a look at(s): Sham Alpha-Stim SCS

Examine abstract: Fifty-seven army topics (46 males) with insomnia had been randomized to Alpha-Stim SCS machine (60 minutes for five days) or to sham. Complete sleep time adjustments failed to achieve ranges of significance however trended towards a rise on days with remedy, with out lasting adjustments in sleep time at 3 or 10 days publish remedy. The authors concluded that it was secure, 2 with minor unintended effects resulting in discontinuation of examine (worsened sleep, headache), and confirmed promise however not conclusive enchancment in whole sleep time notably for males.

Quotation: Morriss R, Patel S, Boutry C, Patel P, Guo B, Briley PM, Butler D, Craven M, Duncan A, Griffiths C, Higton F, McNaughton R, Nixon N, Prasad V, Sayal Okay, Sensible D, Zafar A, Kai J. Scientific effectiveness of energetic Alpha-Stim AID versus sham Alpha-Stim AID in main despair in major care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised managed trial. Lancet Psychiatry. 2023 Mar;10(3):172-183. doi: 10.1016/S2215-0366(23)00007-X. Epub 2023 Jan 29. PMID: 36724796.

DOI: https://doi.org/10.1016/s2215-0366(23)00007-x

URL: https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(23)00007-X/fulltext

Business Assist: Sure

Validation examine: Sure

Comparability take a look at(s): Sham Alpha-Stim AID

Examine abstract: 200 and thirty-six topics (77 males, imply 38.0 years) with despair had been recrutited from English major care facilities, randomized into Alpha-Stim AID with microcurrent, fixed-dose CES (100 μA) or sham, and adopted for 16 weeks to watch for adjustments in despair scores. There have been 17 adversarial results (17 machine/ 8 sham) together with one suidal ideation and hosptilization. There have been no variations in pre-and publish Hamilton Despair scores for both group.

Quotation: Morriss R, Xydopoulos G, Craven M, Value L, Fordham R. Scientific effectiveness and price minimisation mannequin of Alpha-Stim cranial electrotherapy stimulation in remedy in search of sufferers with reasonable to extreme generalised nervousness dysfunction. J Have an effect on Disord. 2019 Jun 15;253:426-437. doi: 10.1016/j.jad.2019.04.020. Epub 2019 Apr 15. PMID: 31103808.

DOI: https://doi.org/10.1016/j.jad.2019.04.020

URL: https://www.sciencedirect.com/science/article/abs/pii/S0165032718325023?viapercent3Dihub

Business Assist: Sure

Validation examine: Sure

Comparability take a look at(s): N/A

Examine abstract: 100 and sixty-one in any other case wholesome sufferers with nervousness and/or despair, who had been ready for cognitive behavioral remedy (CBT) for nervousness, acquired Alpha-Stim AID (60 minutes day by day) for 6-12 weeks. GAD-7 rating at baseline considerably improved from imply (SD) of 15.77 (3.21) to eight.92 (5.42) and eight.99 (6.18) at 12 and 24 weeks respectively (p < 0.001). A secondary final result measure was enchancment in insomnia utilizing the Athens Insomnia Scale (AIS). Baseline imply (SD) AIS of 12.91 (4.82) considerably improved to eight.81 (4.86) and seven.94 (4.62) at 12 and 24 weeks respectively (p<0.001). Sufferers weren't randomized and there was no management group.

Quotation: Taylor AG, Anderson JG, Riedel SL, Lewis JE, Kinser PA, Bourguignon C. Cranial electrical stimulation improves signs and useful standing in people with fibromyalgia. Ache Manag Nurs. 2013 Dec;14(4):327-335. doi: 10.1016/j.pmn.2011.07.002. Epub 2011 Oct 6. PMID: 24315255.

DOI: https://doi.org/10.1016/j.pmn.2011.07.002

URL: https://www.painmanagementnursing.org/article/S1524-9042(11)00136-6/summary

Business Assist: No

Validation examine: No

Comparability take a look at(s): N/A

Examine abstract: Forty-six sufferers (43 females) with fibromyalgia had been randomized into Alpha-Stim, sham, and traditional care teams. The authors reported that the CES machine group had extra lower ache (p=.023), fatigue (p=.071), and sleep disturbance utilizing the Common Sleep Disturbance Scale (p=.001), and improved useful standing (p=.028) in comparison with sham or traditional care teams. Notably, this examine used an uncommon methodology to check examine arms; p-values mirror distinction in slope of fashions based mostly on questionnaire scores.