Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 11:53 PM
Study NCT ID:
NCT06799260
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Cortex Plasticity Response to Theta-Burst Stimulation After Ketone Monoester Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a partial crossover study.\n\nThe study protocol involves two interventions administered sequentially during each visit:\n\nSupplement intervention (KME/placebo) followed after one hour by a stimulation intervention (iTBS/cTBS).\n\nThere will be two separate groups of subjects undergoing different TBS protocols (iTBS vs cTBS).\n\nThe subjects of each group will crossover the supplement intervention (KME and placebo) in two visits separated by one week.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor evoked potential (MEP)', 'timeFrame': 'Pre-TBS (baseline) and post-TBS at 0, 5, 10, 20, and 30 minutes.', 'description': 'Peak-to-peak MEP amplitude elicited by single-pulse TMS over the left M1 representation of the first dorsal interosseous (FDI) muscle.\n\nIn each MEP measurement, 12 MEP readings will be collected, elicited by single-pulse TMS at an intensity of 120% resting motor threshold and separated by 15 seconds.\n\nIn each timepoint post-TBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-TBS (aka, baseline MEPs) using the following equation: (conditioned MEP amplitude/baseline MEP amplitude) × 100. A value of 90-110 represents no change, while values \\< 90% represent suppression and \\> 110% facilitation of the M1 plasticity following TBS.'}], 'secondaryOutcomes': [{'measure': 'TMSens_Q questionnaire', 'timeFrame': 'At 30 minutes post-TBS stimulation', 'description': 'Self-reported side effects using the TMSens\\_Q questionnaire to evaluate the tolerability of the KME-TBS combination.'}, {'measure': 'Corticospinal excitability indices', 'timeFrame': 'Pre-KME supplementation and at 1 hour post-KME supplementation', 'description': 'Resting motor threshold (RMT) followed by motor-evoked potential at 120% RMT intensity'}, {'measure': 'Blood pressure', 'timeFrame': 'Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and serially thereafter every 3-5 minutes until 30 minutes post-TBS', 'description': 'Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) using fully automated oscillometric sphygmomanometer'}, {'measure': 'Heart rate', 'timeFrame': 'Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and continuously thereafter for 30 minutes post-TBS', 'description': 'Heart rate (bpm) using pulse oximeter'}, {'measure': 'Blood glucose', 'timeFrame': 'Pre-KME supplementation and at 30 minutes post-TBS stimulation', 'description': 'On-site using a portable glucometer'}, {'measure': 'Blood beta-hydroxybutyrate', 'timeFrame': 'Pre-KME supplementation and at 30 minutes post-TBS stimulation', 'description': 'On-site using a portable glucometer'}, {'measure': 'Serum brain-derived neurotrophic factor', 'timeFrame': 'Pre-KME supplementation and at 30 minutes post-TBS stimulation', 'description': 'Serum levels of mature brain-derived neurotrophic factor (mBDNF) and pro-BDNF isoforms'}, {'measure': 'BDNF genetic polymorphism', 'timeFrame': 'At the baseline (pre-KME supplementation)', 'description': 'BDNF rs6265 single nucleotide polymorphism'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial magnetic stimulation', 'Intermittent theta-burst stimulation', 'Continuous theta-burst stimulation', 'Primary motor cortex', 'Neuroplasticity', 'ketone monoester', 'Beta-hydroxybutyrate', 'Brain-derived neurotrophic factor', 'Blood pressure', 'Heart rate'], 'conditions': ['Healthy Young Adult', 'Neurophysiology']}, 'descriptionModule': {'briefSummary': 'Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent- and continuous-theta burst stimulation (iTBS/cTBS) are increasingly used protocols to enhance or suppress M1 excitability, respectively, beyond stimulation. However, the poor reproducibility and high inter-individual variability in responses to TBS protocols are matters of concern. This study will explore whether ketone monoester supplementation can boost TBS efficacy via their mechanistic convergence on Brain-Derived Neurotrophic Factor (BDNF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young adults (18-35 years old)\n* Right-handed\n* Fully vaccinated against COVID-19\n\nExclusion Criteria:\n\n* Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS safety\n* Highly active subjects (athletes)\n* Obese (BMI ≥ 30 kg/m2)\n* Smokers\n* Following intermittent fasting or ketogenic diet\n* Long COVID-19'}, 'identificationModule': {'nctId': 'NCT06799260', 'acronym': 'KME-TBS', 'briefTitle': 'Motor Cortex Plasticity Response to Theta-Burst Stimulation After Ketone Monoester Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Priming Effects of Ketone Monoester Supplementation on Theta-Burst Stimulation-Induced Plasticity in the Primary Motor Cortex', 'orgStudyIdInfo': {'id': 'JKEUPM-2021-485'}, 'secondaryIdInfos': [{'id': 'FRGS/1/2022/SKK01/UPM/02/4', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Higher Education, Malaysia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KME then placebo supplement with iTBS stimulation', 'description': 'KME drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with iTBS stimulation over the left M1 hand region', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo', 'Device: iTBS']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then KME supplement with iTBS stimulation', 'description': 'Placebo drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with iTBS stimulation over the left M1 hand region', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo', 'Device: iTBS']}, {'type': 'EXPERIMENTAL', 'label': 'KME then placebo supplement with cTBS stimulation', 'description': 'KME drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with cTBS stimulation over the left M1 hand region', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo', 'Device: cTBS']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then KME supplement with cTBS stimulation', 'description': 'Placebo drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with cTBS stimulation over the left M1 hand region', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo', 'Device: cTBS']}], 'interventions': [{'name': 'Ketone Monoester (KME)', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg/kg body weight of the KME supplement', 'armGroupLabels': ['KME then placebo supplement with cTBS stimulation', 'KME then placebo supplement with iTBS stimulation', 'Placebo then KME supplement with cTBS stimulation', 'Placebo then KME supplement with iTBS stimulation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taste-matched placebo drink', 'armGroupLabels': ['KME then placebo supplement with cTBS stimulation', 'KME then placebo supplement with iTBS stimulation', 'Placebo then KME supplement with cTBS stimulation', 'Placebo then KME supplement with iTBS stimulation']}, {'name': 'iTBS', 'type': 'DEVICE', 'description': 'iTBS stimulation will be applied using a butterfly figure-of-eight Cool-B70 coil connected to a MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).', 'armGroupLabels': ['KME then placebo supplement with iTBS stimulation', 'Placebo then KME supplement with iTBS stimulation']}, {'name': 'cTBS', 'type': 'DEVICE', 'description': 'cTBS stimulation will be applied using a butterfly figure-of-eight Cool-B70 coil connected to a MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).', 'armGroupLabels': ['KME then placebo supplement with cTBS stimulation', 'Placebo then KME supplement with cTBS stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43400', 'city': 'Serdang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Sultan Abdul Aziz Shah', 'geoPoint': {'lat': 3.03333, 'lon': 101.71667}}], 'overallOfficials': [{'name': 'Wan Aliaa Wan Sulaiman, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Universiti Putra Malaysia'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/', 'ipdSharing': 'YES', 'description': 'Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wan Aliaa Wan Sulaiman', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}