[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658670":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":26,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":70,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":26,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Nottingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Beta oscillations","Beta oscillations in response to attentional tasks as measured by OPM-MEG","Baseline",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Disability","Childhood Health Assessment Questionnaire (CHAQ) a validated questionnaire to measure disability in children",{"measure":18,"description":19,"timeFrame":12},"Anxiety and Depression","Revised Child anxiety and Depression scale - a validated questionnaire to assess anxiety and depression in children",{"measure":21,"description":22,"timeFrame":12},"Pain-related worrying","Pain Catastrophizing Scale (PCS) is a valid questionnaire assessing pain-related worrying",{"measure":24,"description":25,"timeFrame":12},"Post-traumatic-sress","Child Post Traumatic Stress Disorder symptoms scale is a valid questionnaire to assess childhood post traumatic stress disorder related symptoms",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","CROSS_SECTIONAL","In the orthopaedic clinic Parents of children aged 7-12 years will be screened for the study from the usual care team provided with a participant information sheet and invitation letter. Potential participants will be approached by a member of the research team at a subsequent follow up appointment for recruitment into the study. All participants will provide informed consent signed by the parent or guardian in the clinic room upon recruitment by a member of the research staff. Children (aged 7-12) will sign to confirm assent. Parents\u002Fguardians will be given a form to fill in their contact details, and a validated age appropriate questionnaire to complete before the study appointment. \\[The Multisensory Amplification Scale (Dan Wang and Megan Loux, 2022) will asses the participants sensory processing. The Revised Child Anxiety and Depression Scale (RCADS) (Chorpita et al., 2005) will assess the participants' anxiety and depression.\\]\n\nAt home An appointment letter will be emailed or posted to the participants, in line with their preferred contact method. A reminder text message will be sent a few days prior to their appointment. Participants will have a study appointment arranged on the same day as their follow-up appointment to orthopaedics or at an alternative convenient time. The participants will complete the questionnaire with the help of their parent\u002Fguardian at home before the study appointment. This will take roughly 20-30 minutes, including schedules breaks.\n\nStudy appointment At the research visit, children will attend the Sir Peter Mansfield Imaging Centre (SPMIC) at the University of Nottingham for an appointment 1-1.5 hours (allows for technical difficulties). The OPM-MEG is integrated into a helmet (effectively a modified bicycle helmet). The child will wear this helmet throughout the scanning session, and this will allow the passive measurement of MEG data.\n\nWe will use OPM-MEG to record brain activity during rest (tactile-free) and in response to a tactile and visual stimuli.\n\nThe tactile attention task involves brief, gentle stimulation to the index fingers using braille-style devices while the participant watches a video of their choice. Stimulation is delivered using a set of custom-built braille cells mounted on a wooden platform, allowing for comfortable and stable hand placement. A single trial comprised approximately 0.5s of stimulation during which the finger is tapped 3 times using all 8 pins. Pins are up for 82ms during each 'tap' and down for 82ms between 'taps'). This is followed by 3 s rest. The finger stimulates the index finger. There is a total of 42 trials for each finger, meaning the experiment lasts a total of 294 seconds (5 minutes).\n\nThe visual stimulation to measure gamma activity comprises of an inwardly moving circular grating moving at 1.2°s-1. The grating is displayed centrally at 100% contrast and subtended a visual angle of 7.6°, with 1.32 cycles per degree. A single trial comprises 1000 ms of stimulation followed by a jittered rest period with a white fixation cross located centrally on a black screen for 1250 ± 200 ms. Sixty trials in total are shown and these circles trials are interspersed with images of faces. The total time for this task is roughly 5 minutes.\n\nAll devices have been safety tested for use with human volunteers and pose no risk to the participants, and are well tolerated. At all times the child's parent\u002Fguardian will remain in the study room with them. The experimenter and parent\u002Fguardian can communicate via an intercom set-up, ensuring the comfort of the child and parent throughout the study. Participants will also be continuously monitored on a video camera within the scanning suite. If the child becomes distressed at any point the study will be stopped, and only restarted if both the parent\u002Fguardian and their child are happy. The child will also be able to watch a TV program\u002Ffilm during the study to ensure that they remain comfortable.\n\nA typical recording session will last approximately 40 minutes allowing for technical difficulties. It will consist of:\n\n* Two 5 minute recording blocks and one 5-10 minute resting state recording block. The participant will be watching a standardised video on screen for both tasks and resting state recording.\n* We will need to record the shape of the child's head- this will be done using an Einscan. This creates a 3D image of the head with, and without the helmet on to accurately record the locations of the sensors on the scalp.","Individuals adolescents (aged 7-12 years old) who have recently, in the past 8 weeks, had a musculoskeletal intervention (e.g. traumatic injury, long bone fracture, scoliosis correction) requiring the administration of opiate medication as part of routine care.",[33],{"label":34,"type":26,"description":35,"interventionNames":26},"Opioid exposure","Individuals aged 7-12 years old with exposure to opiate medication for musculoskeletal intervention, e.g. traumatic injury, long bone fracture, scoliosis correction)",[37],{"name":38,"affiliation":5,"role":39},"Ben Marson, MB BCh BSc PhD FRCS","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Stephanie Smith, BSc (Hons), MRes, PhD, PGCHE","CONTACT","+44115 823 1942","Stephanie.Smith2@Nottingham.ac.uk",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Gareth Hathway, PhD","+441158230152","gareth.hathway@nottingham.ac.uk",[51],{"facility":5,"status":26,"city":52,"state":26,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Nottingham","NG7 UH","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-1.15047,52.9536,{"lat":60,"lon":59},[63,66,67],{"name":38,"role":43,"phone":64,"phoneExt":26,"email":65},"000","ben.marson@Nottingham.ac.uk",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},{"name":68,"role":69,"phone":26,"phoneExt":26,"email":26},"Olivia Wade, BSc","SUB_INVESTIGATOR",{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100658670","opioid-analgesia-impacts-on-neurological-development-100658670",false,"NCT07855952","Opioid Analgesia Impacts on Neurological Development","The Long-term Impact of Opioid Analgesia in Children and Young People on Long-term Neurological Development.","OPAL","Inclusion Criteria:\n\n* Individuals aged 7-12 years\n* Had a recent (within 8 weeks) musculoskeletal intervention (e.g. traumatic injury, long bone fracture, scoliosis correction) requiring administration of opioids by their clinical care team\n* Parent\u002Fguardian who can give informed consent on behalf of the child\n\nExclusion Criteria:\n\n* Terminal\u002Funcontrolled medical or mental health conditions that would prevent them from completing the study assessments or pose a significant risk to participants or staff\n* Insufficient understanding of spoken or written English to comply with the requirements of the study protocol\n* Inability to adhere to the study protocol\n* Taken opiate medication in the last 7 days\n* Epilepsy\n* Cerebral Palsy","ALL","7 Years","12 Years",{"count":84,"type":85},30,"ESTIMATED","OBSERVATIONAL","Background: Pain in childhood - whether from injuries like fractures or long-term conditions like scoliosis - is often treated with opioid medicines. These drugs are effective for pain relief. Recent research suggests that they may affect brain development if given during key stages of growth. This study will explore how different types of pain and opioid use impact brain activity in children using a child-friendly brain scan called OPM-MEG.\n\nObjectives:\n\n1. To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles.\n2. To investigate the relationships between brain activity and clinical features, including subjective pain ratings, pain sensitivity, and psychological outcomes (e.g. trauma symptoms, distress).\n\nParticipants will be asked to attend a single visit, which may coincide with their follow-up clinical appointment to orthopaedics or at an alternative convenient time. The visit will take approximately 1-1.5 hours and consist of recording brain activity using the child-friendly OPM-MEG (like a bicycle helmet) during rest and in response to a variety of sensory stimuli. Participants will also be asked to complete a small number of questionnaires.",[89,90,91,92,93],"Fracture","Scoliosis Idiopathic Adolescent","Traumatic Injury","Adolescent","Dislocation",[95,96,97],"Brain Imaging","Opioid","Musculoskeletal","NOT_YET_RECRUITING","2026-09-28",{"date":101,"type":102},"2026-10-02","ACTUAL",{"date":104,"type":85},"2026-09",{"date":106,"type":85},"2026-09-30",{"name":5,"class":6},1]