[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Subjects were enrolled in the study if they were 2–18 yearsof age and had received a previously documented diagnosis ofASD and a targeted neural profile (high delta/high theta and/orhigh beta) associated with autistic disorders was confirmedbyqEEG evaluation. Furthermore, since the therapy was goingto be administered via a device requiring to be connectedto a computer, the availability of an Internet connection wasnecessary for all subjects. Moreover, since the study testingwas done in our clinic in Orlando FL, the parents of acceptedsubjects agreed that they would be responsible to come to theclinic at the beginning of the study and after 12 weeks of homebased therapy and that they would bear the expenses associatedwith the visits
Excluded criteria: Subjects were excluded if they had a historyofhearing impairment and co-morbidities such as Rett-Syndrome.
Intervention Characteristics
Intervention
Control
Funktionsniveau, forældrebedømt, QAFB, lower better (mean SE)
Kernesymptomer, forældrebedømt, SRS-SCI index, lower better (mean SE)
Kernesymptomer, klinikerbedømt, ABC Total, lower better (mean SE)
Eksekutiv funktion, BRIEF global executive composite, lower better (mean SE)
Sponsorship source: We wish to thank the Carrick Institute, Plasticity Brain Centersand Neurotech International Limited for funding and equipmentutilized in this investigation.ACKNOWLEDGMENTSWe wish to thank the Carrick Institute, Plasticity Brain Centersand Neurotech International Limited for funding and equipmentutilized in this investigation. As always we are indebted totheCarrick Institute and the Bedfordshire Centre for Mental HealthResearch in association with the University of Cambridge. We aregrateful to the clinical and support staff of the Orlando PlasticityBrain Center for their assistance in conducting this study at theirfacility with special appreciation to Jamie Norman and MatthewAntonucc
Country: usa
Setting: Carrick Institute, Plasticity Brain Centers
Comments:
Authors name: Frederck R Carrick
Institution: Neurology, Carrick Institute,
Email: Neurology, Carrick Institute,
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Not reported
Excluded criteria: Not reported
Intervention Characteristics
Intervention
Control
Kernesymptomer autisme, forældrerapporteret, ATEC total, lower better
Sponsorship source: Not reported
Country: 36), Atlantic Highlands, NJ 07716.
Setting: Atlantic Research Institute, Inc
Authors name: Betty Jarusiewicz
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were an age between 8 and 12 years, an IQ-score of 80 and above, and the presence of autistic disorder,Asperger disorder or PDD-NOS according to the DSM-IV criteria as clinically diagnosed by a certified child psychiatrist orhealth care psychologist.
Excluded criteria: Excluded were children using medication, children with a history of severe brain injury, and children with co-morbidity such as ADHD and epilepsy.
Intervention Characteristics
Intervention
Control
Kernesymptomer autisme, forældrerapporteret, SRS total score, lower better
Sponsorship source: We thank MindMedia for theirshare in the availability of neurofeedback equipment.
Country: The Netherlands
Setting: Behavioural Science Institute, Radboud University Nijmegen, P.O. Box 9104, 6500 HE Nijmegen, The Netherlands
Comments:
Authors name: Mirjam E.J. Kouijzer
Institution: Behavioural Science Institute, Radboud University Nijmegen,
Email: m.kouijzer@pwo.ru.nl
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were an age between 12and 18 years, an IQ-score of 80 or above and the presence of autistic disorder, Asperger disorder or PDD-NOS asclinically diagnosed by a certified child psychiatrist or health care psychologist, according to the DSM-IV-TRcriteria (American Psychiatric Association2000).
Excluded criteria: Excluded were students with a history of severe brain injury orcomorbid diagnoses such as ADHD and epilepsy as diagnosed by a certified child psychiatrist or health care psy-chologist.
Intervention Characteristics
Intervention
Control
Sponsorship source: We offerthanks to Fonds NutsOhra, who financially supported this researchproject. We thank MindMedia for sharing in the availability of bio-feedback equipment and BrainClinics Nijmegen for providing us withbiofeedback supplies
Country: The Netherlands
Setting: Behavioural Science Institute, Radboud University Nijmegen,
Authors name: mirjam Kouijzer
Institution: Behavioural Science Institute, Radboud University Nijmegen,
Email: mirjamkouijzer@gmail.com
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria:
Study 1:Parentswere asked to provide evidence of outside diagnosis of high functioning ASD, which included anIQ > 80. Only those assessed by a clinician and meeting the criteria were included. Participantswere randomly assigned to placebo (n = 3) or experimental (n = 5) conditions and neitherparticipants nor parents were informed of group membership until after final testing wascompleted.
Study 2: All participants were considered high-functioning, defined as having ageappropriate verbal comprehension abilities and an Intelligence Quotient (IQ) greater than80 as assessed by a standardized IQ test.
Intervention Characteristics
Intervention
Kernesymptomer autisme, forældrerapporteret, ATEC total, lower better
Eksekutiv funktion, TOVA ADHD SCORES, lower better
Sponsorship source: Cure Autism Now, US Grants, and Chancellor’s Scholarships
Country: US
Authors name: J.A. Pineda
Institution: Department of Cognitive Science, University of California, San Diego, 9500 Gilman Drive,La Jolla, CA 92093-0515, United States
Email: pineda@cogsci.ucsd.edu
Address: Department of Cognitive Science, University of California, San Diego, 9500 Gilman Drive,La Jolla, CA 92093-0515, United States
Wrong study design
Wrong intervention
Wrong intervention
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "Subjects were randomly assigned to two groups: Active (receiving the actual therapy) and Control (receiving a placebo/sham therapy)."
Judgement Comment: Insufficient information on sequence generation
Quote: "The children were divided into pairs, matching gender, age, and extent of autism as best as possible. Each pair was then randomly divided into a group for neurofeedback training and a control group. Controls were assured that they too would be trained with neurofeedback at the conclusion of the approximately six to eight months."
Judgement Comment: Insufficient information on sequence generation
Quote: "Participants were randomly appointed to the neurofeedback treatment and the control group, although this resulted in uneven balanced diagnoses over groups."
Judgement Comment: Insufficient information on sequence generation
Quote: "These participants were randomly assigned to the EEG-biofeedback, SC-bio- feedback or waiting list group."
Judgement Comment: Insufficient information on sequence generation
Judgement Comment: Insufficient information on sequence generation
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "Subjects in the Control group used a device identical to the Mente Autism device, but the binaural beats were randomly generated and not based on the EEG pattern recorded by the device."
Judgement Comment: Low risk of bias for participants, high risk of bias for personnel. Blinding of participants and personnel not feasible and is likely to influence reporting of outcome
Judgement Comment: Blinding of participants and personnel not feasible, and outcome reproting is likely to be influenced
Judgement Comment: Blinding of participants and personnel not feasible, and is likely to influence the reporting of outcome
Quote: "Participants and parents were blinded for treatment allocation to EEG- or SC-biofeedback groups, but not for the waiting list group."
Judgement Comment: CGI filled out by unblinded personell, outcome likely to be influenced by lack of blinding
Judgement Comment: States that it is double-blinded, but it is unclear how this was performed
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Blinding of outcome assessors is not feasible and is likely to influence reporting of outcome
Judgement Comment: Blinding of outcome assessors not feasible and reporting of outcome is likely to be influenced
Judgement Comment: Blinding of outcome assessors is not feasible, and is likely to influence the reporting of outcome
Judgement Comment: Blinding of outcome assessors not feasible and is likely ti influence reporting of outcomes
Judgement Comment: Personell not blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Approximately half of the population in both groups dropped out and no imputations have been placed.
Judgement Comment: Large dropout rate, and no attempts to impute data were made
Judgement Comment: No flowchart or description of dropout/missing data. Apparently there are no missing data in the study
Judgement Comment: Apparently there are no missing data
Quote: "One subject in the experimental group dropped out midway through the training."
Judgement Comment: Apparently very low rate of missing data
Reporting bias due to selective outcome reporting
Judgement Comment: The study protocol and reporting match
Judgement Comment: No variance was provided on the reporting of the results. No protocol, unclear if outcomes are left out
Judgement Comment: There is no reference to study protocol, but appears to report on relevant outcomes
Judgement Comment: No reference to study protocol, but analyses are subdivided into regulators and non-regulators
Judgement Comment: There is no reference to study protocol, but appears to report on outcomes of interest
Bias due to problems not covered elsewhere in the table
Quote: "We wish to thank the Carrick Institute, Plasticity Brain Centers and Neurotech International Limited for funding and equipment utilized in this investigation."
Judgement Comment: First author leader of Carrick Institute that produces Mente Device Auditory feedback - outcomes likely to be influenced by vested interests.
Quote: "Betty Jarusiewicz is Founder, Principal Investigator and Program Director, Atlantic Research Institute, Inc. She serves on the Board of Directors of EEG Spectrum Interna- tional, Inc. (ESII). NeuroCybernetics, Inc., a subsidiary of ESII, developed the soft- ware used in this study."
Judgement Comment: Conflict of interest, not reported
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias