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BCI

Phase 2

Attention Deficit Hyperactivity Disorder | Unknown | Psychiatry |National Healthcare Corp.|Last Updated: Mar 30, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

Clinical trial landscape

BCI · 1 trial · 1 indication

Phase 2 1
NCT01344044Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
COMPLETED192 Analytics
PHASE2COMPLETED
Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition
Week 0, 8, 20, 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCI treatmentACTIVE_COMPARATORBCI treatment will commence during the week of the Baseline.
Wait-list controlOTHERBCI treatment will commence 8 weeks after Baseline
BCI pilot armEXPERIMENTALThis is a experimental arm to test out the safety and effectiveness of BCI in improving ADHD symptoms. This pilot arm is necessary as the BCI device, incorporating dry electrode sensors and intervention game, is newly developed and have not been tested out in children with ADHD. This preliminary study will also allow us to test out the treatment protocol (24 sessions of BCI training over 8 weeks) to see if it is efficacious.

Interventions

NameTypeDescription
BCIDEVICE24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
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Eligibility Criteria

Age Range6 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000) Exclusion Criteria: * Present or history of medical treatment with stimulant medication and Atomoxetine * Co-morbid...

Countries:Singapore
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Frequently asked questions about BCI

What is BCI used for in Attention Deficit Hyperactivity Disorder?

BCI is an investigational intervention being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is currently in Phase 2 clinical development. The drug is being evaluated for its potential to address symptoms of ADHD, though it is not yet approved by regulatory authorities.

Who makes BCI?

BCI is being developed by National Healthcare Corp., a company listed on the stock exchange under the ticker symbol NHC. The company is conducting clinical research to evaluate the safety and efficacy of BCI for the treatment of Attention Deficit Hyperactivity Disorder.

What phase is BCI in?

BCI is currently in Phase 2 clinical development. It is an investigational drug being studied for Attention Deficit Hyperactivity Disorder. The Phase 2 trial has been completed, and the drug is not yet approved by regulatory agencies. Further clinical studies may be needed to establish its safety and efficacy.

What clinical trials is BCI in?

BCI has been studied in one clinical trial, identified as NCT01344044. This Phase 2 trial, titled 'Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)', was completed and enrolled 192 participants in Singapore. The trial included children aged 6 years and older with ADHD.

Is BCI the same as a brain-computer interface?

BCI is the drug name used in the clinical trial, which is described as a brain-computer interface based intervention. The trial title refers to BCI as an intervention for ADHD, suggesting it may involve a technology-based approach rather than a traditional pharmaceutical. However, the specific mechanism of action is not disclosed.