NeurofeedbackNCT05254769
Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
A study testing Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany. in people with Neurofeedback and Autistic Disorder, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
This project aims to: explore the effectiveness of Neurofeedback therapy for children diagnosed with Autism Spectrum Disorder (ASD) assess if cognitive functions are affected before and after Neurofeedback Intervention Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Neurofeedback, Autistic Disorder, Autism Spectrum Disorder
- What is being tested?
- Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to May 2022
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7 to 17 year olds (diagnosed by their physician with autism, in accordance with DSM-V (Diagnostic Statistical Manual-V) diagnostic criteria
Who cannot join
- Brain injury
- Bipolar Disorder
- Tourette's Syndrome
- Uncontrolled seizure disorder
- Major psychiatric disorder
- Children on medications
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Federal Medical and Dental College, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, 44000
Shemaila Saleem, MPhil, MPH, 0923315106766, drshemailasaleem@gmail.com, shemailasaleem@fmdc.edu.pk
Hamid Habib, PhD, 0923335247457, dr.hamidhabib@gmail.com, hamid.habib@kmu.edu.pk
About this study
This project aims to:
- explore the effectiveness of Neurofeedback therapy for children diagnosed with Autism Spectrum Disorder (ASD)
- assess if cognitive functions are affected before and after Neurofeedback Intervention
Read the detailed description
Neurofeedback is a computer assisted programmed technique that functions by tracing brain electrical activity (EEG) and providing feedback about the brain activity and sends visual and acoustic signals to counter the mismatch in the electrical activity for improvement. It is a course of learning that allows the patient to observe, regulate and modify his/her own brain activity. Neurofeedback will be carried out in 35 children with Autism Spectrum Disorder (ASD) over a 30-session training period to improve the cognitive functions. This study aims to improve the behavioural and cognitive functions of children and adolescents with Neurofeedback therapy. As Neurofeedback therapy is a non-invasive treatment with almost no side effects, this study will contribute to practice of effective and scalable assessment and treatment strategy for children and adolescents with ASD, utilizing objective tools that have not widely been used in the assessment of Cognitive functions for ASD.
Goal is to improve the quality of life of children on the spectrum by enabling them to perform day to day activities of life and to improve their social communication. Moreover, this study seeks to be a contribution for creating mass awareness regarding the efficacy of Neurofeedback therapy especially in the developing world. Hopefully in the future Neurofeedback training would be incorporated as a standard of care for ASD.
- Being tested
- Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.
- Keywords
- Neurofeedback, Autism Spectrum Disorder
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.Device
The EEG NeuroAmp (Electroencephalogram Amplifier) is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP (Event related potential) measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback Intervention in children with Autism Spectrum Disorder | Experimental | Neurofeedback therapy will be provided to 35 children with Autism Spectrum Disorder 30 sessions each and cognitive domains will be assessed before and after intervention. Receives: Device: Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale (CARS)
Childhood Autism Rating Scale (CARS) is designed as a clinical rating scale for trained clinician to rate items indicative of Autism Spectrum Disorder (ASD) after direct observation of child.The form is used with individuals of all ages and in both clinical and research settings.
Measured: Baseline
IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM)
Tests have been designed to measure as unambiguously as possible, educative and reproductive abilities. It is designed for use with young children and old people, or for those with poor language skills for whatever reason.
Measured: Baseline
Reward sensitivity testing
Neurofeedback is an operant conditioning so the responsiveness and non- responsiveness of the subjects can be attributed to the reward sensitivity. Reward sensitivity for children and adolescents with autism will be assessed by Reward Responsiveness Scale.
Measured: Baseline
Secondary outcomes (4)
Changes in Flanker Inhibitory Control and Attention Score
Flanker Inhibitory Control and Attention Score measures the allocation of one's limited capacities to deal with an abundance of environmental stimulation. It is an assessment of attention and executive Function It will be used to investigate if Neurofeedback therapy affect it and how much. Flanker Inhibitory Control and Attention Score measures the allocation of one's limited capacities to deal with an abundance of environmental stimulation. It is an assessment of attention and executive Function It will be used to investigate if Neurofeedback therapy affect it and to what extent.
Measured: Baseline, at 10 weeks and 18 weeks
Changes in Dimensional Change Card Sort Score; Cognitive Flexibility
Dimensional Change Card Sort Score measures the capacity to plan, organize and monitor the execution of behaviours that are strategically directed in a goal-oriented manner. It is also an assessment of executive functions.
It will be used to investigate if Neurofeedback therapy affects it and to what extent.
Measured: Baseline, at 10 weeks and 18 weeks
Changes in List Sorting Working Memory Score
List Sorting Working Memory Score measures the ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. It is an assessment of working memory It will be used to investigate if Neurofeedback therapy affects it and to what extent.
Measured: Baseline, at 10 weeks and 18 weeks
Changes in Pattern Comparison Processing Speed Score
Pattern Comparison Processing Speed Score assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed.
It will be used to investigate if Neurofeedback therapy affects it and to what extent.
Measured: Baseline, at 10 weeks and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start15 Nov 2021
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofeedbackStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm Pre and Post intervention Design
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Responsible party
- Principal investigator, Dr. Shemaila Saleem, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Shemaila Saleem, Principal investigator, FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PakistanHamid Habib, Principal investigator, Khyber Medical University, Peshawar, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254769
- Sponsor's protocol ID
- NFB
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Intervention in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT05254769
- Acronym / sponsor ID
- NFB
- Keywords
- Neurofeedback, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 24 Feb 2022 (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.
This project aims to:
- explore the effectiveness of Neurofeedback therapy for children diagnosed with Autism Spectrum Disorder (ASD)
- assess if cognitive functions are affected before and after Neurofeedback Intervention
Detailed description
Neurofeedback is a computer assisted programmed technique that functions by tracing brain electrical activity (EEG) and providing feedback about the brain activity and sends visual and acoustic signals to counter the mismatch in the electrical activity for improvement. It is a course of learning that allows the patient to observe, regulate and modify his/her own brain activity. Neurofeedback will be carried out in 35 children with Autism Spectrum Disorder (ASD) over a 30-session training period to improve the cognitive functions. This study aims to improve the behavioural and cognitive functions of children and adolescents with Neurofeedback therapy. As Neurofeedback therapy is a non-invasive treatment with almost no side effects, this study will contribute to practice of effective and scalable assessment and treatment strategy for children and adolescents with ASD, utilizing objective tools that have not widely been used in the assessment of Cognitive functions for ASD.
Goal is to improve the quality of life of children on the spectrum by enabling them to perform day to day activities of life and to improve their social communication. Moreover, this study seeks to be a contribution for creating mass awareness regarding the efficacy of Neurofeedback therapy especially in the developing world. Hopefully in the future Neurofeedback training would be incorporated as a standard of care for ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm Pre and Post intervention Design
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Intervention in children with Autism Spectrum Disorder | Experimental | Device: Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.Neurofeedback therapy will be provided to 35 children with Autism Spectrum Disorder 30 sessions each and cognitive domains will be assessed before and after intervention. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7 to 17 year olds (diagnosed by their physician with autism, in accordance with DSM-V (Diagnostic Statistical Manual-V) diagnostic criteria
Key exclusion criteria (6 listed)
- Brain injury
- Bipolar Disorder
- Tourette's Syndrome
- Uncontrolled seizure disorder
- Major psychiatric disorder
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 |
|---|---|---|
| Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany.The EEG NeuroAmp (Electroencephalogram Amplifier) is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP (Event related potential) measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. | Device | Neurofeedback Intervention in children with Autism Spectrum Disorder |
Primary outcome
Childhood Autism Rating Scale (CARS)
Time frame: Baseline
Childhood Autism Rating Scale (CARS) is designed as a clinical rating scale for trained clinician to rate items indicative of Autism Spectrum Disorder (ASD) after direct observation of child.The form is used with individuals of all ages and in both clinical and research settings.
IQ (Intelligence Quotient) scoring (Colored Progressive Matrices (CPM)
Time frame: Baseline
Tests have been designed to measure as unambiguously as possible, educative and reproductive abilities. It is designed for use with young children and old people, or for those with poor language skills for whatever reason.
Reward sensitivity testing
Time frame: Baseline
Neurofeedback is an operant conditioning so the responsiveness and non- responsiveness of the subjects can be attributed to the reward sensitivity. Reward sensitivity for children and adolescents with autism will be assessed by Reward Responsiveness Scale.
4 secondary outcomes
Changes in Flanker Inhibitory Control and Attention Score
Time frame: Baseline, at 10 weeks and 18 weeks
Changes in Dimensional Change Card Sort Score; Cognitive Flexibility
Time frame: Baseline, at 10 weeks and 18 weeks
Changes in List Sorting Working Memory Score
Time frame: Baseline, at 10 weeks and 18 weeks
Changes in Pattern Comparison Processing Speed Score
Time frame: Baseline, at 10 weeks and 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- 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.
Shemaila Saleem principal investigator
FM&DC, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan
Hamid Habib principal investigator
Khyber Medical University, Peshawar, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback Equipment (Cygnet) by BEE Medic GmbH Technologies, Baden-Wurttemberg, Germany. in people with Neurofeedback and Autistic Disorder, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 1 inclusion and 6 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 8 Mar 2022. 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 Pakistan. 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 Associate Professor (0923315106766, drshemailasaleem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (CARS) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 8 Mar 2022.