A Single-blind, Randomised, Sham Controlled, Phase IIa Exploratory Clinical Trial, to Examine the Safety and Efficacy of BGX-3006 (tPCS) on Paediatric ADHD Participants.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 主要终点
- The primary efficacy objective will be measured by the change in scores from baseline to Day 42 in both the SNAP-IV-C and Connors'3 Parent Rating Scales
研究概览
简要总结
Children with ADHD display a certain brainwave profile which might be different to that of a child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation) has shown that this brainwave profile could possibly be altered to more closely resemble a brainwave profile of a child who does not have ADHD. Researchers believe that by changing this brainwave profile it might lessen symptoms of ADHD.
tPCS is a name used to describe the type of current this device produces. It involves randomly (in no specific pattern) produced pulses of current at different times that the brain picks up. These pulses of low current stimulate the brain in a certain way and affect the brainwave activity.
Treatment is given by applying a low frequency current using small electrodes clipped to the earlobes. The current comes from an external battery source. The pulses of current generated by this device stimulate certain parts of the brain which result in a possible increased control of attention and behaviour. This treatment has already been proven to be safe and will not hurt your child.
Due to these specific parts of the brain being stimulated, and the positive results of previous research, it seems possible to control certain functions in children suffering from inattention and hyperactivity.
The idea of using tPCS stimulation as a possible way for helping children with confirmed ADHD opens a new window to future research. The final goal of this device and research is to offer a safe, non-invasive (conservative treatment that does not require piercing into the body or the removal of tissue) treatment that can be used on a long-term basis and shows a clear improvement of ADHD symptoms for children and even adults with ADHD.
详细描述
- Inspection of Records: Investigators and institutions involved in the trial will permit trial-related monitoring, audits, Independent Ethics Committee (IEC) review, and regulatory inspection(s) by providing direct access to all trial records. In the event of an audit, the investigator agrees to allow the sponsor, representatives of the sponsor and applicable regulatory authorities access to all trial records. The confidentiality of records that can identify participants will be protected, respecting the privacy and confidentiality rules in accordance with regulatory requirements.
The investigator must promptly notify the sponsor of any audits scheduled by any regulatory authorities and promptly forward copies of any audit reports received to the sponsor.
In order to ensure data accuracy, data for individual participant visits must be completed as soon as possible/ during/ immediately following the visit. All completed data will be reviewed, signed, and dated by the investigator in a timely manner.
- Database Management and Quality Control: Data management, including the development and management of a database, will be performed in accordance with regulatory requirements. The designated data management vendor will review the CRF data for completeness and accuracy. A formal querying process will be followed whereby the data management group will request the site personnel to clarify any apparent erroneous entries or inconsistencies and will request additional information from the site as required.
Medical history/current medical conditions and adverse events will be coded using the Medical dictionary for regulatory activities (MedDRA) terminology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the written informed consent process for trial participation, by parent(s) or legal guardian(s), prior to all trial-related procedures
- •Completion of written assent for trial participation, by participant, prior to all trial-related procedures
- •Male or female participants aged 6 to 12 years
- •Newly diagnosed (Diagnosis made by DSM-V criteria), treatment naïve participants
- •Participants and parent(s) or legal guardian(s) must have the ability to communicate well with the investigator and to understand and comply with the requirements of the trial
- •Participants and parent(s) or legal guardian(s) must agree to stay in contact with the trial site for the duration of the trial and provide updated contact information as necessary.
排除标准
- •Existence of a major neurologic or psychiatric condition (epilepsy, severe depression etc.)
- •History of head injury resulting in more than a momentary loss of consciousness
- •Previous neurosurgery
- •Presence of unstable medical conditions, such as: Diabetes Mellitus, Cardiac Pathology, Cancer, Kidney Insufficiency, Acute Thrombosis
- •Presence of any implanted metal or electronic medical devices present in the head, excluding any dental implants
- •Subjects on any prohibited concomitant medication
- •Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial
- •In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial
结局指标
主要结局
The primary efficacy objective will be measured by the change in scores from baseline to Day 42 in both the SNAP-IV-C and Connors'3 Parent Rating Scales
时间窗: 42 days
Safety and tolerability will be measured by the incidence and severity of adverse events and changes in physical examination findings, vital signs and qEEG findings.
时间窗: 42 days
次要结局
- The secondary efficacy objective will be measured by the change in scores from baseline to day 42 in the psychometric analysis conducted by the psychometrist(42 days)
- The change from baseline to day 42 in the electrophysiological observations of a qEEG.(42 days)