ADHDNCT04378699
2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
A study testing SMR (12-15 Hz) and alpha band (8 -12Hz) in people with ADHD, run by Fondation Lenval at 1 site in France.
Trial summary
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- ADHD
- What is being tested?
- SMR (12-15 Hz) and alpha band (8 -12Hz)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children or teenagers between 8 and 15 years old included
- Subject with mixed-type ADHD (attention deficit hyperactivity disorder) diagnosed by a specialist physician in the field and according to Diagnosis and Statistics of Mental Disorders-5 (DSM-5) criteria.
- Subject of any psychotropic treatment for at least 15 days before inclusion
- Subject committing not to take any treatment during the study period, nor to participate in another therapeutic treatment in parallel.
- Subject available and pledging to honor the two weekly neurofeedback sessions for 15 consecutive weeks, and be available for symptom monitoring at 6 months.
- Child benefiting from a Social Security scheme.
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- Non Inclusion Criteria:
- Neurological disorders (epilepsy)
- Trouble of the autistic spectrum
- Active disorder without hyperactivity (TDA)
- Bad understanding of the French language
- Low Intellectual Level (IQ <70 Cognitive Assessment)
- Lack of understanding of the constraints inherent in the protocol
- Inability to comply with the constraints of the study throughout its duration
Who cannot join
- premature termination of participation, withdrawal of the patient's voluntary informed consent
- Investigator's or sponsor's decision
- Withdrawal of consent of subjects or legal guardians
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux pédiatriques de Nice CHU Lenval
Nice, 06200
Hervé MD CACI, MD, 04 92 03 05 69 ext. 0033, caci.h@pediatrie-chulenval-nice.fr
Hervé MD CACI, MD
About this study
Official title: Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic.
The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
Read the detailed description
Attention deficit disorder with or without hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic. In the symptomatic triad of inattention, impulsivity and hyperactivity, there is often a psychopathological disorder, a learning and / or sleep disorder. Medication treatment with methylphenidate is the reference in terms of prescription to reduce the symptoms of AD / HD. However, the limitations of its long-term effectiveness, tolerance of side effects, and parental distrust of psychostimulant treatment are gradually opening the door to new therapeutic approaches.
Neurofeedback is considered by the scientific world as a promising and effective neurocognitive learning technique in the treatment of Attention Deficit Disorder with Hyperactivity ADHD and several neurological and psychiatric disorders. Its principle is to increase the patient's ability to regulate his own brain activity, captured by an ElectroEncephaloGram (EEG), after visual and auditory feedback.
In this controlled and randomized research, the investigator will compare the effects of two neurofeedback protocols on the repercussions of AD / HD symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
Seventy children and adolescents aged 7 to 15 in two groups will benefit from thirty neurofeedback sessions each, either on a so-called Sensory Motor Rhythm (SMR) protocol or on a protocol called Upper Alpha. To date, no studies have identified the effects of a NF Upper Alpha protocol on improving sleep, hyperactivity and comorbidities in patients with ADHD in a controlled and randomized manner. nor on personality dimensions related to the processes of self-regulation of the patient involved in Neurofeedback (NF) treatment.
The investigator expects superior clinical improvement of ADHD symptoms and sleep disorders in the NF upper alpha training group in patients not following any parallel drug or therapy regimen. The investigator expects stability of the effects of treatment after several months of stopping neurofeedback sessions, without taking or recovery of psychostimulant.
This research protocol would make it possible for dozens of children and adolescents to benefit from an alternative treatment (in the absence of placebo conditions) in order to achieve a clinical improvement of at least 30% of their patients. symptoms related to AD / HD, as well as to develop a field of research still little investigated in France. On the other hand, parents would be more likely to accept effective neurofeedback treatment than psychostimulant treatment, especially since it may have side effects. In addition, the validation of clinical improvements following a neurofeedback protocol aimed at increasing the relative power of alpha waves at frontal sites would be encouraging for clinical practice and future research in this area.
- Conditions
- ADHD
- Being tested
- SMR (12-15 Hz), alpha band (8 -12Hz)
- Keywords
- ADHD, neurofeedback
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMR (12-15 Hz)Other
SMR training sessions (12-15 Hz) C4 unipolar placement, central region
alpha band (8 -12Hz)Other
3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region
| Study group | Role | What they receive |
|---|---|---|
| SMR Sensory Motor Rhythm (12-15 Hz) | Experimental | 3 X 10 SMR workout sessions (12-15 Hz) C4 unipolar placement, central region Receives: Other: SMR (12-15 Hz) |
| the alpha band (8 -12Hz) | Experimental | 3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region Receives: Other: alpha band (8 -12Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)
ADHD symptoms will be assessed using the clinician version of the 18-item Attention-Deficit with Hyperactivity rating scale IV (ADHD-RS). Each item is scored on a 0-3 scale with 0 representing the absence of the behavior/symptom and 3 representing the very frequent and impairing behavior/symptom over the last months. Two subscales compose ADHD-RS: 9-item Inattention subscale (range: 0-27) and a Hyperactivity-Impulsivity subscale (range: 0-27). The total ADHD-RS score is the sum of the two subscale scores and ranges from 0 to 54.
Effectiveness of a neurofeedback protocol on the training capacity will be defined as a decrease of at least 30% the ADHD-RS total score between baseline, after 15 workout sessions of neurofeedback (2 sessions per week) and another 15 workout sessions of neurofeedback (2 sessions per week). Patients completing the study will therefore have undergone 30 workout sessions of neurofeedback
Measured: scores between baseline and after 15 weeks
Secondary outcomes (6)
Stability of change in ADHD symptoms after 6-month follow-up
The ADHD-RS total score will be rated after a 6-month follow-up period of time to assess the stability of changes compared with the last workout session of neurofeedback. Stability is defined as absolute variation of 10% of the ADHD-RS total score.
Measured: scores between 15 weeks and after 6 months
Scores on Inattention and Hyperactivity-Impulsivity components of ADHD during a neurofeedback protocol
The changes on the Inattention and Hyperactivity-Impulsivity subscores of the ADHD-RS will be described: baseline, after 15 workout sessions of neurofeedback (2 sessions per week) and after another 15 workout sessions of neurofeedback (2 sessions per week). We expect a significant diminution of either or both scores compared with baseline (repeated testing)..
Measured: scores between baseline and after 7weeks and after 15 weeks
Sleep quality during a neurofeedback protocol using a questionnaire
Sleep quality will be assessed by the 19-item Pittsburgh Sleep Quality Index (PSQI) questionnaire filled by the patient with support of his/her parents at baseline, after 15 workout sessions of neurofeedback, after another 15 workout sessions of neurofeedback and after a 6-month follow-up period of time. The first four items are open while the next 15 items are rated on a 0 to 3 scale. Seven component scores are generated and further added to provide an overall score ranging from 0 to 21, lower scores denoting a healthier sleep quality.
Measured: between baseline and after 15 weeks and after 6 months
Executive functions rated during a neurofeedback protocol
Executive functions are assessed using the Behavioral Performance Evaluation Inventory questionnaire (BRIEF) at baseline, after another 15 workout sessions of neurofeedback and after a 6-month follow-up period of time. When possible, both the Parent and Teacher versions of the BRIEF are filled out.
The BRIEF questionnaire counts 86 items groups in eight non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity) and two validity scales. The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite. Scale scores are converted to T-scores providing information about the child's individual scores relative to the scores of other respondents in the standardization sample
Measured: scores between baseline and after 15 weeks and after 6 months
Clinical Improvement during a neurofeedback protocol and after 6-month follow-up
Clinical severity will be assessed at baseline using Guy's Global Clinical Impression scale (CGI-S).The clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Ratings range to 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).
Clinical improvement will be assessed at baseline, after 15 workout sessions of neurofeedback after 30 workout sessions of neurofeedback and after a 6-month follow-up period of time. The clinician rates how much the patient's illness has improved or worsened relative to a state at the beginning of the protocol. Ratings range to 1 (Very much improved) to 7 (Very much worse).
Measured: Evolution between baseline and after 15 weeks and after 6 months
Computerized measures of attention and impulsivity during a neurofeedback protocol
A task-oriented computerised assessment of attention-related problem, the Conners Continuous Performance Test 3rd Edition (CPT-3), will be performed at baseline, after 15 workout sessions of neurofeedback, after another 15 workout sessions of neurofeedback and after a 6-month follow-up period of time. Lasting 14 minutes of time, the CPT-3 provides objective information about inattentiveness, impulsivity, sustained attention, and vigilance. The patient's results are compared with a large normative sample of 1,400 subjects
Measured: at baseline, after 15 weeks and after 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start21 Jan 2018
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center interventional biomedical research with direct individual benefit, randomized with two active arms (without placebo)
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé MD CACI, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378699
- Sponsor's protocol ID
- 16-HPNCL-03
- Status last verified
- Sep 2023
- First submitted
- 7 Nov 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04378699
- Acronym / sponsor ID
- 16-HPNCL-03
- Conditions
- ADHD
- Keywords
- ADHD, neurofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic.
The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
Detailed description
Attention deficit disorder with or without hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic. In the symptomatic triad of inattention, impulsivity and hyperactivity, there is often a psychopathological disorder, a learning and / or sleep disorder. Medication treatment with methylphenidate is the reference in terms of prescription to reduce the symptoms of AD / HD. However, the limitations of its long-term effectiveness, tolerance of side effects, and parental distrust of psychostimulant treatment are gradually opening the door to new therapeutic approaches.
Neurofeedback is considered by the scientific world as a promising and effective neurocognitive learning technique in the treatment of Attention Deficit Disorder with Hyperactivity ADHD and several neurological and psychiatric disorders. Its principle is to increase the patient's ability to regulate his own brain activity, captured by an ElectroEncephaloGram (EEG), after visual and auditory feedback.
In this controlled and randomized research, the investigator will compare the effects of two neurofeedback protocols on the repercussions of AD / HD symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
Seventy children and adolescents aged 7 to 15 in two groups will benefit from thirty neurofeedback sessions each, either on a so-called Sensory Motor Rhythm (SMR) protocol or on a protocol called Upper Alpha. To date, no studies have identified the effects of a NF Upper Alpha protocol on improving sleep, hyperactivity and comorbidities in patients with ADHD in a controlled and randomized manner. nor on personality dimensions related to the processes of self-regulation of the patient involved in Neurofeedback (NF) treatment.
The investigator expects superior clinical improvement of ADHD symptoms and sleep disorders in the NF upper alpha training group in patients not following any parallel drug or therapy regimen. The investigator expects stability of the effects of treatment after several months of stopping neurofeedback sessions, without taking or recovery of psychostimulant.
This research protocol would make it possible for dozens of children and adolescents to benefit from an alternative treatment (in the absence of placebo conditions) in order to achieve a clinical improvement of at least 30% of their patients. symptoms related to AD / HD, as well as to develop a field of research still little investigated in France. On the other hand, parents would be more likely to accept effective neurofeedback treatment than psychostimulant treatment, especially since it may have side effects. In addition, the validation of clinical improvements following a neurofeedback protocol aimed at increasing the relative power of alpha waves at frontal sites would be encouraging for clinical practice and future research in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-center interventional biomedical research with direct individual benefit, randomized with two active arms (without placebo)
| Arm | Type | Receives |
|---|---|---|
| SMR Sensory Motor Rhythm (12-15 Hz) | Experimental | Other: SMR (12-15 Hz)3 X 10 SMR workout sessions (12-15 Hz) C4 unipolar placement, central region |
| the alpha band (8 -12Hz) | Experimental | Other: alpha band (8 -12Hz)3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Children or teenagers between 8 and 15 years old included
- Subject with mixed-type ADHD (attention deficit hyperactivity disorder) diagnosed by a specialist physician in the field and according to Diagnosis and Statistics of Mental Disorders-5 (DSM-5) criteria.
- Subject of any psychotropic treatment for at least 15 days before inclusion
- Subject committing not to take any treatment during the study period, nor to participate in another therapeutic treatment in parallel.
- Subject available and pledging to honor the two weekly neurofeedback sessions for 15 consecutive weeks, and be available for symptom monitoring at 6 months.
Key exclusion criteria (3 listed)
- premature termination of participation, withdrawal of the patient's voluntary informed consent
- Investigator's or sponsor's decision
- Withdrawal of consent of subjects or legal guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMR (12-15 Hz)SMR training sessions (12-15 Hz) C4 unipolar placement, central region | Other | SMR Sensory Motor Rhythm (12-15 Hz) |
| alpha band (8 -12Hz)3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region | Other | the alpha band (8 -12Hz) |
Primary outcome
Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)
Time frame: scores between baseline and after 15 weeks
ADHD symptoms will be assessed using the clinician version of the 18-item Attention-Deficit with Hyperactivity rating scale IV (ADHD-RS). Each item is scored on a 0-3 scale with 0 representing the absence of the behavior/symptom and 3 representing the very frequent and impairing behavior/symptom over the last months. Two subscales compose ADHD-RS: 9-item Inattention subscale (range: 0-27) and a Hyperactivity-Impulsivity subscale (range: 0-27). The total ADHD-RS score is the sum of the two subscale scores and ranges from 0 to 54. Effectiveness of a neurofeedback protocol on the training capacity will be defined as a decrease of at least 30% the ADHD-RS total score between baseline, after 15 workout sessions of neurofeedback (2 sessions per week) and another 15 workout sessions of neurofeedback (2 sessions per week). Patients completing the study will therefore have undergone 30 workout sessions of neurofeedback
6 secondary outcomes
Stability of change in ADHD symptoms after 6-month follow-up
Time frame: scores between 15 weeks and after 6 months
Scores on Inattention and Hyperactivity-Impulsivity components of ADHD during a neurofeedback protocol
Time frame: scores between baseline and after 7weeks and after 15 weeks
Sleep quality during a neurofeedback protocol using a questionnaire
Time frame: between baseline and after 15 weeks and after 6 months
Executive functions rated during a neurofeedback protocol
Time frame: scores between baseline and after 15 weeks and after 6 months
Clinical Improvement during a neurofeedback protocol and after 6-month follow-up
Time frame: Evolution between baseline and after 15 weeks and after 6 months
Computerized measures of attention and impulsivity during a neurofeedback protocol
Time frame: at baseline, after 15 weeks and after 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé MD CACI principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMR (12-15 Hz) and alpha band (8 -12Hz) in people with ADHD, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé MD CACI (04 92 03 05 69 ext. 0033, caci.h@pediatrie-chulenval-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD) (time frame: scores between baseline and after 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.