Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202608566224029 Date of Registration: 13/08/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing neurofeedback and behavioral memory training in children with mild intellectual disability
Official scientific title Feasibility and Preliminary Signals of Neurofeedback Versus Behavioral Working-Memory Training in Children With Mild Intellectual Disability: A Nonrandomized Active-Comparator Pilot Trial
Brief summary describing the background and objectives of the trial Children with mild intellectual disability commonly experience working-memory difficulties that can affect learning, following instructions, problem solving, adaptive functioning, and everyday independence. Neurofeedback and structured behavioral working-memory training are two reinforcement-based approaches that may strengthen attention, rehearsal, response organization, and resistance to distraction; however, evidence comparing these approaches in children with mild intellectual disability remains limited. This active-comparator pilot study therefore aimed to determine whether a 24-session EEG neurofeedback programme and a 24-session behavioral working-memory training programme could be feasibly delivered to children aged 9–12 years with mild intellectual disability. It also aimed to examine preliminary changes in working-memory performance from baseline to post-intervention and two-week follow-up in each intervention group. In addition, exploratory quantitative EEG measurements were collected in the neurofeedback group to examine possible changes in selected EEG frequency bands across the training period. The study was designed as a feasibility and signal-detection pilot and was not intended to establish treatment efficacy, superiority, equivalence, or long-term effectiveness.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/01/2024
Actual trial start date 05/01/2024
Anticipated date of last follow up 03/03/2024
Actual Last follow-up date 17/03/2024
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 10
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group EEG Neurofeedback Training 24 individual sessions, delivered twice weekly; approximately 25 minutes per session. 3 months Participants received theta/beta EEG neurofeedback training at the Fz electrode site using a game-based visual feedback task. Beta1 activity at 13–21 Hz was reinforced, while theta activity at 4–8 Hz was inhibited, with the aim of reducing the theta/beta ratio. A one-minute baseline was used to establish adaptive thresholds at the beginning of each session. The game progressed when beta activity increased and theta activity decreased relative to the threshold and stopped when the desired EEG pattern was not maintained. Sessions were conducted individually under professional supervision. 5
Control Group Behavioral Working Memory Training 24 individual sessions delivered twice weekly, approximately 30 minutes per session. 3 months Participants received structured behavioral working memory training targeting visual and auditory working memory. The program used positive reinforcement, modelling, prompting, corrective feedback, repetition, discrete-trial practice, play-based activities, dialogue, and homework. Activities included recalling visual and numerical sequences, identifying details in hidden images, delayed classification tasks, following conditional instructions, retelling stories in reverse order, recognizing sounds, predicting story outcomes, and retrieving items in reverse sequence. Task difficulty was increased gradually according to participant performance. 5 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 9 and 12 years Diagnosis of intellectual disability according to DSM-5-TR criteria IQ score within the mild intellectual disability range of 55–70 Written informed consent provided by a parent or legal guardian Child assent obtained where developmentally appropriate Severe behavioral problems that could prevent participation Chronic medical conditions that could interfere with the intervention procedures Current participation in another intervention with similar target outcomes Comorbid neurodevelopmental conditions Multiple disabilities Child: 6 Year-12 Year 9 Year(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2024 Research Ethics Committee Faculty of Medicine Beni Suef University Faculty of Arts Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Faculty of Arts Beni-Suef University, Salah Salem Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in total working memory score measured using the 31-item Arabic Working Memory Scale, including visual and auditory working memory components. Baseline before intervention and immediately after completion of the 24-session intervention, approximately 3 months after baseline.
Secondary Outcome Change in resting-state quantitative EEG frequency-band amplitudes and ratios in the neurofeedback group, including delta, theta, alpha, SMR, Beta1, Beta2, gamma, theta/beta, theta/SMR, and alpha/theta measures. Baseline, after session 8, after session 16, and immediately after completion of session 24.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Tarbya Al Fekrya School Beni-Suef Beni Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rania Fawzy Salah Salem St. Beni Suef Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Salah Salem St. Beni Suef 6251 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Fawzy raniafawzy@art.bsu.edu.eg 201005053849 Beni Suef University Salah Salem Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Corresponding author and investigator Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Zienab Mady Zienab.mady@ssn.bsu.edu.eg 0020105612345 Beni Suef University Salah Salem Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Beni Suef University Beni Suef Egypt
Role Name Email Phone Street address
Scientific Enquiries Sahar Ibrahim Saharhassan2010@yahoo.com 0020110003567 Beni Suef University Salah Salem Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Beni Suef University Beni Suef Egypt
Role Name Email Phone Street address
Scientific Enquiries Amira Nada miraabdelrahmannada@gmail.com 00201100373860 Beni Suef University Salah Salem Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Beni Suef University Beni Suef Egypt
Role Name Email Phone Street address
Scientific Enquiries Shanoo Sheikh sskeikh@pnu.edu.sa 0096655224487 Jeddah
City Postal code Country Position/Affiliation
Riyadh 11671 Saudi Arabia Assistant Professor Princess Nourah bint Abdulrahman University
Role Name Email Phone Street address
Scientific Enquiries Mostafa ElKholy Mostafaelkholy@med.bsu.edu.eg 0020110304789 Salah Salem St
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Associate professor Beni Suef University
Role Name Email Phone Street address
Public Enquiries Rania Fawzy raniafawzy@art.bsu.edu.eg 00201005053849 Beni-Suef University, Salah Salem Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Corresponding Author Beni Suef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this trial may be made available upon reasonable written request to the corresponding author. Data sharing will be subject to approval by the relevant research ethics committee, protection of participant confidentiality, and completion of an appropriate data-use agreement. No directly identifiable participant information will be shared. Statistical Analysis Plan,Study Protocol Data may be requested following publication of the primary trial report and will remain available for five years after publication, subject to continued ethical and institutional approval. Access may be granted to qualified researchers who submit a methodologically sound proposal for scientific verification, secondary analysis, or evidence synthesis. Requests must specify the research objectives, requested variables, analysis plan, data-security arrangements, and intended outputs. Approval by the corresponding author and the relevant research ethics committee, together with a signed data-use and confidentiality agreement, will be required before data are released.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/07/2026 Result - 29/07/2026 Result - 29/07/2026 Result - 29/07/2026 Result - 29/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/08/2026 Thank you for your review. I confirm the following. Issuing bodies. This study was reviewed and approved jointly by the Faculty of Arts Social and Human Sciences Ethics Committee (ARTBSU-SHS-REC) in collaboration with the Faculty of Medicine Research Ethics Committee, Beni-Suef University. The joint review reflects the composition of the research team, which draws investigators from both the Faculty of Arts and the Faculty of Medicine; the behavioural and social-science components were reviewed by the Arts committee and the neurophysiological (neurofeedback) components by the Medicine committee. The letter is signed by the Chair of each committee and countersigned by the Committee Secretary, and bears both faculty seals. The approval reference carries the FMBSUREC prefix because the file was registered under the Faculty of Medicine committee's numbering system as co-approving body. Chronology. Ethical approval was granted on 20 December 2024. We have verified the study chronology and corrected the trial-registration record to confirm that participant recruitment and trial commencement occurred only after ethical approval was granted on that date. No study procedure was undertaken before approval was in force. The 2026 date on the uploaded document. The document previously uploaded is a reissued copy, not a new or extended approval. It was reissued on 25 February 2026 at the request of the committee secretariat, because the journal considering the manuscript required the approval to appear on current letterhead with an explicit validity period. The reissued letter states the original approval date of 20 December 2024 on its face and remains valid until 24 January 2027. No protocol amendment, re-review, or change of scope occurred. Correction requested. We have also requested correction of the approval reference printed on the reissued ethics letter, to ensure consistency with the issuing committee, recipient, and approved project. I have uploaded the original ap TRUE, Research Ethics Committee Faculty of Medicine Beni Suef University , Faculty of Medicine, Beni-Suef University, Salah Salem , Beni Suef, 62511, Egypt, , 02 Jan 2024, +20822356845, Rec.fm@med.bsu.edu.eg, 43800_40127_4737.pdf TRUE, Research Ethics Committee Faculty of Medicine Beni Suef University Faculty of Arts Beni Suef University, Faculty of Medicine, Faculty of Arts Beni-Suef University, Salah Salem , Beni Suef, 62511, Egypt, , 02 Jan 2024, +20822356845, Rec.fm@med.bsu.edu.eg, 43800_40127_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 05/08/2026 Source Name corrected from "Self" to the actual name of the Principal Investigator providing the funding, as requested by the trial reviewer. Funding source type remains self-funded. Self, Beni Suef, Beni Suef, 62511, Egypt, Self Funded, Rania Fawzy, Salah Salem St. Beni Suef, Beni Suef, 62511, Egypt, Self Funded,