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NCT Number: NCT06799260

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Young Adult Neurophysiology

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, 43400, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketone Monoester (KME)

Dietary Supplement

500 mg/kg body weight of the KME supplement

Placebo

Dietary Supplement

Taste-matched placebo drink

iTBS

Device

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).

cTBS

Device

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).

Primary outcomes

  1. Motor evoked potential (MEP)

    Time frame: 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 outcomes

  1. TMSens_Q questionnaire

    Time frame: At 30 minutes post-TBS stimulation

    Self-reported side effects using the TMSens_Q questionnaire to evaluate the tolerability of the KME-TBS combination.

  2. Corticospinal excitability indices

    Time frame: Pre-KME supplementation and at 1 hour post-KME supplementation

    Resting motor threshold (RMT) followed by motor-evoked potential at 120% RMT intensity

  3. Blood pressure

    Time frame: 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

  4. Heart rate

    Time frame: Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and continuously thereafter for 30 minutes post-TBS

    Heart rate (bpm) using pulse oximeter

  5. Blood glucose

    Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation

    On-site using a portable glucometer

  6. Blood beta-hydroxybutyrate

    Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation

    On-site using a portable glucometer

  7. Serum brain-derived neurotrophic factor

    Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation

    Serum levels of mature brain-derived neurotrophic factor (mBDNF) and pro-BDNF isoforms

  8. BDNF genetic polymorphism

    Time frame: At the baseline (pre-KME supplementation)

    BDNF rs6265 single nucleotide polymorphism

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • University of Oxford

Registry information

Official study title

Priming Effects of Ketone Monoester Supplementation on Theta-Burst Stimulation-Induced Plasticity in the Primary Motor Cortex

Acronym: KME-TBS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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