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NCT ID: NCT04421248 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder Combined

Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder

AMPAIII
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: "Cognitive Control" and "Emotional Valence." Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.

NCT ID: NCT04416360 Completed - Clinical trials for Autism Spectrum Disorder

Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak

CLIECO
Start date: May 5, 2020
Phase: N/A
Study type: Interventional

In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).

NCT ID: NCT04412499 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder

OPTIME-TDAH
Start date: May 1, 2020
Phase:
Study type: Observational

The Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children and adolescents. The diagnosis is clinical with the input of several informants (child, family, teachers, …). ADHD is a risk factor for academic difficulties, school dropout, social isolation, injury, oppositional behaviour. In school-age children and adolescents having moderate to high or persistent impairment despite psycho-educational support and environmental modification, the first-line treatment is methylphenidate. Group or individual cognitive behavioural therapy for parents and/or children and adolescents is recommended for co-occurring disorders and persistent impairment. In France, the initiation of methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist, and a regular medical supervision (weight, heart rate, blood pressure, …). At least once a year, the indication of methyphenidate needs to be re-evaluated and confirmed at the hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives including non-psychostimulants should be considered. A randomized controlled trial evaluated the dose of methylphenidate received over a period of 13 months. It was observed that the "combined treatment" group (methylphenidate + psychosocial treatments) received a lower average dose of methylphenidate than the "methylphenidate alone" group. These results are difficult to extrapolate to the general population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of total remission). For a global consideration of children's needs, it is important to better understand the interactions between these two therapeutic approaches. To participate in the study, parents will have to complete an online questionnaire. This questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and parenting practices.

NCT ID: NCT04408521 Active, not recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents

NFB@HOME
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home. A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback. Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.

NCT ID: NCT04398225 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder

Start date: June 11, 2020
Phase: Phase 1
Study type: Interventional

This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.

NCT ID: NCT04378517 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder Combined

Evaluating the Feasibility of FAM-SOTC Intervention for Families of Adolescents With ADHD: Pilot Study

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

Attention-deficit/hyperactivity disorder (ADHD), is a highly genetic and complex neurological disorder, where disruptive behavior, emotional imbalance, and lack of attention can interrupt with normal development of adolescents, self-awareness, and self-regulation in a way that has an impact on the family unit. Effective family intervention programs, that empower resilience and strength, to cope with the stressful situation from ADHD, are therefore needed. Nevertheless, there is a lack of knowledge regarding what type of interventions are the most effective for these families. As well as, little is known about the benefits of family-level intervention for families of adolescents with ADHD at outpatient care and what amount of combination in an intervention is appropriate. Psychiatric advanced practical nurse (APN) practitioners are in a key role to offer such an intervention. Therefore, the aim of this pilot study is to evaluate the feasibility of offering a family-level intervention, for parents of 13-17 years old adolescents with ADHD, at a Children and Adolescents' Psychiatric Outpatient Unit (BUGL). Also, to evaluate if the intervention, which consists of group educational sessions, family sessions, and access to evidence-based information's on ADHD, fitted the families. A nurse-led educational and support intervention will be offered for parents of adolescents with ADHD once a week over a 5-week time period. First, there will be offered three group support sessions, with information about the general impact of the ADHD disorder on the family's daily life. Second, two special therapeutic conversations and support interviews will be offered to each family, where each parent can discuss their daily situation specifically and its impact on the family as a whole. Third, caregivers will have access to about 140 pages of evidence-based material on a closed website (pan pale) regarding the ADHD disorder in adolescents and its impact on the family. The outcome of this process will help in determining the feasibility of subjecting the intervention to a more expensive and time-consuming randomized controlled trial (RCT) study.

NCT ID: NCT04375059 Not yet recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Effects of Attention Training on Children

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

NCT ID: NCT04362982 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)

ADHD360
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention.

NCT ID: NCT04355065 Recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

The Secret Trail of Moon (Serious Videogame) and Chess on ADHD: a Clinal Trial

Start date: December 9, 2019
Phase: Phase 2
Study type: Interventional

Blackground: Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest. Especially, the use of Virtual Reality video games. Our team has developed an innovative video game based on Virtual Reality, "The Secret Trail of Moon (TSTM) as a cognitive tool to train 5 main areas of deficit in patients with ADHD. It is superiority study comparing TSTM with therapeutic chess and control group. Methods: This study is prospective, unicentric, randomized with a control group. 105 patients diagnosed with ADHD and pharmacologically stable, aged between 12 and 22 years. These patients will be randomized intro three groups: TSTM group (The Secret Trail of Moon); TC group (Therapeutic Chess) and CG (Control Group). Objective and subjective measures of the patient, parents and teachers will be included. Patients´visit will be different for each group. The TSTM group will have 15 face-to face visits: pre-inclusion visit, inclusion visit, 12 training visits and final visit. CT and GC group patients will have 3 face-to- face visits (pre-inclusion, initial visit and final visit) and 12 email or phone communications during training. Discussion: This study aims to demonstrate the added efficacy of cognitive training to drug treatment. It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training (TC) and a control group. TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique: the feeling of immersion in the scenarios, the variety of mechanics, the personalization and the playful aspect.

NCT ID: NCT04333394 Not yet recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

Start date: April 20, 2020
Phase: N/A
Study type: Interventional

To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating