iTBS Effect on M1 Plasticity, Blood Glucose, and Cardiovascular Response

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-01-01

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 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.

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Detailed Description

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Conditions

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Healthy Young Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active then sham stimulation

Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

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).

Sham

Intervention Type DEVICE

Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head

Sham then active stimulation

Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

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).

Sham

Intervention Type DEVICE

Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head

Interventions

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TMS

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).

Intervention Type DEVICE

Sham

Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head

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 candidacy
* Smokers
* Obese (BMI ≥ 30)
* Highly active subjects
* Active or previous lab-confirmed COVID-19 with long symptoms

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes