Groot onderzoek vindt positieve maar gemengde resultaten van Akili's digitale therapeutisch middel voor kinderen met ADHD

Groot onderzoek vindt positieve maar gemengde resultaten van Akili's digitale therapeutisch middel voor kinderen met ADHD

februari 26, 2020 0 Door admin


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Full pub­li­ca­tion of piv­otal tri­al data out­lines Akil­i’s case for FDA reg­u­la­tion (Mobi­Health­News):

A full tran­script of STARS-ADHD — the piv­otal tri­al of Akili Interactive’s video game-like pedi­atric atten­tion deficit treat­ment — has been pub­lished in The Lancet Dig­i­tal Health jour­nal, pro­vid­ing onlook­ers a clear view of data fuel­ing the dig­i­tal ther­a­peu­tic company’s pend­ing FDA sub­mis­sion … Those in the inter­ven­tion group (n = 180) received a tablet with AKL-T01, which requires play­ers to focus on nav­i­gat­ing an alien avatar through a course while respond­ing to on-screen prompts. The con­trol group (n = 168) received an edu­ca­tion­al word game that was also designed by the com­pa­ny.

The pri­ma­ry out­come of inter­est was the mean change in TOVA API — an objec­tive, val­i­dat­ed mea­sure of atten­tion and inhibito­ry con­trol cleared by the FDA — after the inter­ven­tion peri­od. In this, the researchers saw a greater mean change in scores among the inter­ven­tion group (0.93) than in the con­trol group (0.03 ;adjust­ed p = .006) …

The per­for­mance of Akili’s treat­ment become a lit­tle more con­di­tion­al when review­ing the STARS-ADHD trial’s sec­ondary end­points. These includ­ed a vari­ety of scales and tools that Jina described as mea­sure­ments of behav­ioral or sub­jec­tive cog­ni­tive impact, rather than objec­tive symp­tom changes.

Patients who received AKL-T01 demon­strat­ed sig­nif­i­cant improve­ments across each of these mea­sures — but not enough of a boost to out­pace their peers receiv­ing the sham ther­a­py …  “Under­stand­ing the ben­e­fit of our tech­nol­o­gy when used along­side ADHD med­ica­tions has been a research pri­or­i­ty for us. Impor­tant­ly, par­ents see improve­ments in their chil­dren regard­less of whether they are using the treat­ment alone or along­side stim­u­lants,” Eddie Mar­tuc­ci, CEO of Akili, said last month in an announce­ment of the adjunct trial’s results.

Jina said that these stud­ies, tak­en in con­junc­tion with the company’s oth­er tri­als, should paint a clear enough pic­ture of AKL-T01 for reg­u­la­tors and clin­i­cians alike.”

The Study:

A nov­el dig­i­tal inter­ven­tion for active­ly reduc­ing sever­i­ty of pae­di­atric ADHD (STARS-ADHD): a ran­domised con­trolled tri­al (The Lancet Dig­i­tal Health). From the abstract:

  • Back­ground: Atten­tion-deficit hyper­ac­tiv­i­ty dis­or­der (ADHD) is a com­mon pae­di­atric neu­rode­vel­op­men­tal dis­or­der with sub­stan­tial effect on fam­i­lies and soci­ety. Alter­na­tives to tra­di­tion­al care, includ­ing nov­el dig­i­tal ther­a­peu­tics, have shown promise to reme­di­ate cog­ni­tive deficits asso­ci­at­ed with this dis­or­der and may address bar­ri­ers to stan­dard ther­a­pies, such as phar­ma­co­log­i­cal inter­ven­tions and behav­iour­al ther­a­py. AKL-T01 is an inves­ti­ga­tion­al dig­i­tal ther­a­peu­tic designed to tar­get atten­tion and cog­ni­tive con­trol deliv­ered through a video game-like inter­face via at-home play for 25 min per day, 5 days per week for 4 weeks. This study aimed to assess whether AKL-T01 improved atten­tion­al per­for­mance in pae­di­atric patients with ADHD.
  • Find­ings: Between July 15, 2016, and Nov 30, 2017, 857 patients were eval­u­at­ed and 348 were ran­dom­ly assigned to receive AKL-T01 or con­trol. Among patients who received AKL-T01 (n=180 [52%]; mean [SD] age, 9·7 [1·3] years) or con­trol (n=168 [48%]; mean [SD] age, 9·6 [1·3] years), the non-para­met­ric esti­mate of the pop­u­la­tion medi­an change from base­line TOVA API was 0·88 (95% CI 0·24–1·49; p=0·0060). The mean (SD) change from base­line on the TOVA API was 0·93 (3·15) in the AKL-T01 group and 0·03 (3·16) in the con­trol group. There were no seri­ous adverse events or dis­con­tin­u­a­tions. Treat­ment-relat­ed adverse events were mild and includ­ed frus­tra­tion (5 [3%] of 180) and headache (3 [2%] of 180). Patient com­pli­ance was a mean of 83 (83%) of 100 expect­ed ses­sions played (SD, 29·2 ses­sions).
  • Inter­pre­ta­tion: Although future research is need­ed for this dig­i­tal inter­ven­tion, this study pro­vides evi­dence that AKL-T01 might be used to improve objec­tive­ly mea­sured inat­ten­tion in pae­di­atric patients with ADHD, while pre­sent­ing min­i­mal adverse events.

The Study in Context:

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