Motor Cortex Plasticity Response to Theta-Burst Stimulation After Ketone Monoester Supplementation

Not Applicable

Recruiting

• Conditions: Healthy Young Adult; Neurophysiology

• Registration Number: NCT06799260
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-18
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy young adults (18-35 years old)
• Right-handed
• Fully vaccinated against COVID-19

Exclusion Criteria

• Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS safety
• Highly active subjects (athletes)
• Obese (BMI ≥ 30 kg/m2)
• Smokers
• Following intermittent fasting or ketogenic diet
• Long COVID-19

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Motor evoked potential (MEP)	Pre-TBS (baseline) and post-TBS at 0, 5, 10, 20, and 30 minutes.	Peak-to-peak MEP amplitude elicited by single-pulse TMS over the left M1 representation of the first dorsal interosseous (FDI) muscle.; In 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.; In 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.

Secondary Outcome Measures

Name	Time	Method
TMSens_Q questionnaire	At 30 minutes post-TBS stimulation	Self-reported side effects using the TMSens_Q questionnaire to evaluate the tolerability of the KME-TBS combination.
Corticospinal excitability indices	Pre-KME supplementation and at 1 hour post-KME supplementation	Resting motor threshold (RMT) followed by motor-evoked potential at 120% RMT intensity
Blood pressure	Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and serially thereafter every 3-5 minutes until 30 minutes post-TBS	Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) using fully automated oscillometric sphygmomanometer
Heart rate	Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and continuously thereafter for 30 minutes post-TBS	Heart rate (bpm) using pulse oximeter
Blood glucose	Pre-KME supplementation and at 30 minutes post-TBS stimulation	On-site using a portable glucometer
BDNF genetic polymorphism	At the baseline (pre-KME supplementation)	BDNF rs6265 single nucleotide polymorphism
Blood beta-hydroxybutyrate	Pre-KME supplementation and at 30 minutes post-TBS stimulation	On-site using a portable glucometer
Serum brain-derived neurotrophic factor	Pre-KME supplementation and at 30 minutes post-TBS stimulation	Serum levels of mature brain-derived neurotrophic factor (mBDNF) and pro-BDNF isoforms

Trial Locations

Locations (1)

Hospital Sultan Abdul Aziz Shah; 🇲🇾 Serdang, Selangor, Malaysia