Neudive Inc. has announced a new clinical trial to evaluate its digital therapeutic device, NDTx-02, for improving executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD). The study, currently recruiting participants, combines the device with standard treatment as usual (TAU) to assess its efficacy.
What is the study design?
The pilot study will analyze the effectiveness of the NDTx-02 device alongside TAU. According to the official records available here, it aims to measure improvements in executive function among the enrolled participants. The intervention groups include:
- Group 1: Participants receiving NDTx-02 in combination with TAU.
- Group 2: Participants undergoing TAU alone as a control.
The trial is being conducted under Neudive Inc.’s sponsorship, with patient recruitment ongoing.
Who is eligible?
The study targets children and adolescents diagnosed with ADHD or ASD. Participants must meet specific inclusion criteria outlined by the sponsor. For eligibility information, potential participants should consult the ClinicalTrials.gov resource linked above for full details.
Why is this study important?
This trial holds importance in addressing unmet clinical needs for those facing executive function challenges due to ADHD or ASD. Digital therapeutics, such as NDTx-02, offer innovative, technology-driven solutions that may complement traditional behavioral therapies. Regulatory bodies emphasize adherence to established protocols and the investigation of both efficacy and safety before broader adoption, making this study a critical step.
The combination of NDTx-02 with TAU reflects efforts to integrate cutting-edge technology into standard care practices. Results could inform future device submissions and applications across international medical device markets.
Frequently Asked Questions
1. What conditions is NDTx-02 targeting?
It is designed to address executive function challenges in individuals diagnosed with ADHD or ASD.
2. Are both groups receiving the NDTx-02 device?
No, one group will receive the device with TAU, and the other will undergo TAU as a control.
3. Where can I get more information?
More details are available on ClinicalTrials.gov via this link.
Conclusion
Neudive Inc.’s pilot study on NDTx-02 represents significant progress in using digital therapeutics in ADHD and ASD care. The outcomes will provide insights into executive function improvements and guide future regulatory planning for medical devices. Interested parties are encouraged to visit the official trial page or contact the sponsors for participation details.
Disclaimer
This article is intended for informational purposes and does not constitute legal advice. Clinical and regulatory professionals should refer to official guidelines and consult with experts as needed.
Source link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07242625?term=medical+device