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

NCT ID: NCT06799260

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Healthy Young Adult Neurophysiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a partial crossover study.

The study protocol involves two interventions administered sequentially during each visit:

Supplement intervention (KME/placebo) followed after one hour by a stimulation intervention (iTBS/cTBS).

There will be two separate groups of subjects undergoing different TBS protocols (iTBS vs cTBS).

The subjects of each group will crossover the supplement intervention (KME and placebo) in two visits separated by one week.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KME then placebo supplement with iTBS stimulation

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

Group Type EXPERIMENTAL

Ketone Monoester (KME)

Intervention Type DIETARY_SUPPLEMENT

500 mg/kg body weight of the KME supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taste-matched placebo drink

iTBS

Intervention Type 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).

Placebo then KME supplement with iTBS stimulation

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

Group Type EXPERIMENTAL

Ketone Monoester (KME)

Intervention Type DIETARY_SUPPLEMENT

500 mg/kg body weight of the KME supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taste-matched placebo drink

iTBS

Intervention Type 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).

KME then placebo supplement with cTBS stimulation

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

Group Type EXPERIMENTAL

Ketone Monoester (KME)

Intervention Type DIETARY_SUPPLEMENT

500 mg/kg body weight of the KME supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taste-matched placebo drink

cTBS

Intervention Type 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).

Placebo then KME supplement with cTBS stimulation

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

Group Type EXPERIMENTAL

Ketone Monoester (KME)

Intervention Type DIETARY_SUPPLEMENT

500 mg/kg body weight of the KME supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taste-matched placebo drink

cTBS

Intervention Type 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).

Interventions

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Ketone Monoester (KME)

500 mg/kg body weight of the KME supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Taste-matched placebo drink

Intervention Type DIETARY_SUPPLEMENT

iTBS

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).

Intervention Type DEVICE

cTBS

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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Wan Aliaa Wan Sulaiman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan Aliaa Wan Sulaiman, FRCP

Role: STUDY_CHAIR

Universiti Putra Malaysia

Locations

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Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FRGS/1/2022/SKK01/UPM/02/4

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JKEUPM-2021-485

Identifier Type: -

Identifier Source: org_study_id

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