Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-04-10 @ 8:38 AM
Study NCT ID:
NCT01985750
Status:
UNKNOWN
Last Update Posted:
2018-10-12
First Post:
2013-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Grey matter volume compared with healthy controls', 'timeFrame': 'baseline, week 3, week 8, 3 months following treatment', 'description': 'Difference in regional brain volume related to breathlessness in comparison with healthy controls.'}, {'measure': 'difference in BOLD signal compared with healthy controls', 'timeFrame': 'baseline, week 3, week 8, 3 months following treatment', 'description': 'Difference in FMRI BOLD signal in response to breathlessness cues, in comparison with healthy controls.'}], 'primaryOutcomes': [{'measure': 'BOLD signal changes', 'timeFrame': 'baseline, week 3, week 8, 3 months following treatment', 'description': 'Changes in FMRI BOLD signal in response to breathlessness cues, as a consequence of d-cycloserine administration during pulmonary rehabilitation.'}], 'secondaryOutcomes': [{'measure': 'Grey matter volume', 'timeFrame': 'baseline, week 3, week 8, 3 months following treatment', 'description': 'Change in regional brain volume related to changes in breathlessness as a consequence of d-cycloserine administration during pulmonary rehabilitation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dyspnea', 'fmri', 'd-cycloserine'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40455920', 'type': 'DERIVED', 'citation': 'Finnegan SL, Harrison OK, Ezra M, Harmer CJ, Nichols TE, Rahman NM, Reinecke A, Pattinson KTS. The effect of D-cycloserine on brain connectivity over a course of pulmonary rehabilitation - A randomised control trial with neuroimaging endpoints. PLoS One. 2025 Jun 2;20(6):e0323213. doi: 10.1371/journal.pone.0323213. eCollection 2025.'}, {'pmid': '37020840', 'type': 'DERIVED', 'citation': 'Finnegan SL, Harrison OK, Booth S, Dennis A, Ezra M, Harmer CJ, Herigstad M, Guillaume B, Nichols TE, Rahman NM, Reinecke A, Renaud O, Pattinson KTS. The effect of d-cycloserine on brain processing of breathlessness over pulmonary rehabilitation: an experimental medicine study. ERJ Open Res. 2023 Apr 3;9(2):00479-2022. doi: 10.1183/23120541.00479-2022. eCollection 2023 Mar.'}, {'pmid': '36572534', 'type': 'DERIVED', 'citation': 'Finnegan SL, Browning M, Duff E, Harmer CJ, Reinecke A, Rahman NM, Pattinson KTS. Brain activity measured by functional brain imaging predicts breathlessness improvement during pulmonary rehabilitation. Thorax. 2023 Sep;78(9):852-859. doi: 10.1136/thorax-2022-218754. Epub 2022 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with lung disease, heart failure and cancer. It is often very difficult to treat. The sensations of dyspnoea are processed in the brain, and we believe that psychological factors modify and amplify these sensations, frequently exacerbating symptoms.\n\nThis study aims to identify the importance of learning in the brain mechanisms of dyspnoea by investigating a cohort of patients with chronic breathlessness undergoing pulmonary rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and group therapy that improves dyspnoea but does not improve lung function. This leads us to hypothesise that some of the beneficial effects of PR maybe due to changes in brain processing, potentially relating to a learning effect.\n\nTherefore to probe whether learning is important in the beneficial effects of pulmonary rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is an antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA) receptors in the hippocampus. Our previous study in a similar group of patients demonstrated the importance of the hippocampus in breathlessness perception, and we now wish to investigate this in more depth.\n\nThe study involves collecting physiological, psychological and clinical measures on in conjunction with brain scanning, before, during and once after pulmonary rehabilitation. Subjects will either receive d-cyloserine or placebo before the first four pulmonary rehabilitation sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with chronic lung disease, aged between 45 and 85 years old who have been referred for pulmonary rehabilitation.\n* The subject is able and willing to give fully informed consent.\n\nExclusion Criteria:\n\nAny of the commonly accepted contraindications to MRI scanning, for example, severe claustrophobia, presence of metallic implants, a pacemaker etc.\n\n* Pregnancy. The risk to foetus of radiofrequency energy of the MRI scan is unknown.\n* Inadequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening.\n* Unable to lie flat and still for 1/2 hour\n* Requirements for oxygen therapy\n* Significant cardiac, neurological, psychiatric or metabolic disease\n* Contra-indications to d-cycloserine: Alcoholism, known hypersensitivity, severe renal failure\n* Regular therapy with prescribed opioid analgesics\n* Antidepressant therapy (this may alter hippocampal plasticity)\n* Previous pulmonary rehabilitation (because the learning may be different on repeat pulmonary rehabilitation treatments)'}, 'identificationModule': {'nctId': 'NCT01985750', 'briefTitle': 'Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception', 'orgStudyIdInfo': {'id': 'OX-KP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Drug: d-cycloserine or placebo', 'description': 'Other Names:\n\ncomparison of d-cycloserine or placebo on enhancing the beneficial effects of pulmonary rehabilitation on breathlessness perception\n\n250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D-cycloserine', 'description': 'Placebo Comparator: Drug: d-cycloserine or placebo\n\nOther Names:\n\ncomparison of d-cycloserine or placebo on enhancing the beneficial effects of pulmonary rehabilitation on breathlessness perception\n\n250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation', 'interventionNames': ['Drug: d-cycloserine']}], 'interventions': [{'name': 'd-cycloserine', 'type': 'DRUG', 'otherNames': ['comparison of d-cycloserine or placebo on enhancing the beneficial effects of pulmonary rehabilitation on breathlessness perception'], 'description': '250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation.', 'armGroupLabels': ['D-cycloserine']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Placebo - identically matched to d-cycloserine containing carrier compound only'], 'description': 'Other Names:\n\ncomparison of d-cycloserine or placebo on enhancing the beneficial effects of pulmonary rehabilitation on breathlessness perception\n\n250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation', 'armGroupLabels': ['Drug: d-cycloserine or placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kyle Pattinson, BM DPhil FRCA', 'role': 'CONTACT', 'email': 'kyle.pattinson@nda.ox.ac.uk', 'phone': '+441865 231509'}, {'name': 'Sarah Finnegan, DPhil', 'role': 'CONTACT', 'email': 'copd@fmrib.ox.ac.uk', 'phone': '+441865 234544'}], 'facility': 'Oxford Centre for Clinical Magnetic Resonance Imaging', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Kyle TS Pattinson, BM DPhil FRCA', 'role': 'CONTACT', 'email': 'kyle.pattinson@nda.ox.ac.uk', 'phone': '01865 231 509'}, {'name': 'Sarah Finnegan, DPhil', 'role': 'CONTACT', 'email': 'copd@fmrib.ox.ac.uk', 'phone': '01865 234 544'}], 'overallOfficials': [{'name': 'Kyle TS Pattinson, BM DPhil FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}