Healthy Young AdultsNCT06043076
iTBS Effect on M1 Plasticity, Blood Glucose, and Cardiovascular Response
A study testing TMS in people with Healthy Young Adults, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults (18-35 years old)
- Right-handed
- Fully vaccinated against COVID-19
Who cannot join
- Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS candidacy
- Smokers
- Obese (BMI ≥ 30)
- Highly active subjects
- Active or previous lab-confirmed COVID-19 with long symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Theta-Burst Stimulation on Motor Cortical Plasticity, Blood Glucose, and Cardiovascular Response in Healthy Young Adults
Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. The changes in M1 excitability might in turn be accompanied by other physiological responses in the human body. This study will explore the effect of iTBS protocol on M1 plasticity, heart rate, blood pressure, and blood glucose in healthy young adults in comparison to sham stimulation.
- Conditions
- Healthy Young Adults
- Being tested
- TMS, Sham
- Keywords
- Transcranial magnetic stimulation (TMS), Intermittent theta-burst stimulation (iTBS), Primary motor cortex (M1), Neuroplasticity, Heart rate, Blood pressure, Blood glucose, Healthy, Young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Active iTBS will be applied using a butterfly figure-of-eight C-B60 coil connected to MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).
ShamDevice
Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head
| Study group | Role | What they receive |
|---|---|---|
| Active then sham stimulation | Experimental | Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region Receives: Device: TMS; Device: Sham |
| Sham then active stimulation | Experimental | Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region Receives: Device: TMS; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP)
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 throughout the study, a total of 12 MEP readings, elicited by single pulse TMS at an intensity of 120% resting motor threshold, and separated by 15 seconds, will be collected.
In each time point post-iTBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-iTBS (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% represent facilitation of the M1 plasticity following iTBS.
Measured: Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes
Secondary outcomes (5)
TMSens_Q questionnaire
Self-reported side effects using structured TMSens_Q questionnaire to evaluate the tolerability of iTBS
Measured: At the end of every session
Blood glucose
Capillary blood glucose using portable glucometer
Measured: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Blood pressure
Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) using semi-automated oscillometric sphygmomanometer. Unit of measure: mmHg
Measured: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Heart rate
Heart rate (bpm) using semi-automated oscillometric sphygmomanometer
Measured: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Baseline corticospinal excitability indices
Test-retest reliability of resting motor threshold (RMT) and MEP amplitude
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043076
- Sponsor's protocol ID
- JKEUPM-2023-674
- Status last verified
- Apr 2024
- First submitted
- 4 Sep 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Theta-Burst Stimulation on Motor Cortical Plasticity, Blood Glucose, and Cardiovascular Response in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06043076
- Acronym / sponsor ID
- JKEUPM-2023-674
- Conditions
- Healthy Young Adults
- Keywords
- Transcranial magnetic stimulation (TMS), Intermittent theta-burst stimulation (iTBS), Primary motor cortex (M1), Neuroplasticity, Heart rate, Blood pressure, Blood glucose, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. The changes in M1 excitability might in turn be accompanied by other physiological responses in the human body. This study will explore the effect of iTBS protocol on M1 plasticity, heart rate, blood pressure, and blood glucose in healthy young adults in comparison to sham stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active then sham stimulation | Experimental | Device: TMS, Device: ShamActive iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region |
| Sham then active stimulation | Experimental | Device: TMS, Device: ShamSham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy young adults (18-35 years old)
- Right-handed
- Fully vaccinated against COVID-19
Key exclusion criteria (5 listed)
- Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS candidacy
- Smokers
- Obese (BMI ≥ 30)
- Highly active subjects
- Active or previous lab-confirmed COVID-19 with long symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSActive iTBS will be applied using a butterfly figure-of-eight C-B60 coil connected to MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark). | Device | Active then sham stimulation, Sham then active stimulation |
| ShamSham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head | Device | Active then sham stimulation, Sham then active stimulation |
Primary outcome
Motor evoked potential (MEP)
Time frame: Pre-iTBS (baseline) and post-iTBS at 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 throughout the study, a total of 12 MEP readings, elicited by single pulse TMS at an intensity of 120% resting motor threshold, and separated by 15 seconds, will be collected. In each time point post-iTBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-iTBS (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% represent facilitation of the M1 plasticity following iTBS.
5 secondary outcomes
TMSens_Q questionnaire
Time frame: At the end of every session
Blood glucose
Time frame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Blood pressure
Time frame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Heart rate
Time frame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Baseline corticospinal excitability indices
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Healthy Young Adults, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potential (MEP) (time frame: Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.