Attention Deficit Hyperactivity DisorderNCT06129396
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
A study testing Aerobic exercise and Video-watching in people with Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensity in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes in respect to executive functions. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Aerobic exercise and Video-watching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2023to 1 Oct 2025
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ADHD by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- Adolescents aged between 13-17
- Absence of other neuropsychological disorders including, autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
- Right-handed
Who cannot join
- Presence of other major systematical diseases
- Taking neuropsychological medication within one month, except for medication for ADHD
- With contraindications for non-invasive brain stimulation such as epilepsy, pacemaker or intracranial mental implants
- Color blindness
- Taking part in other studies within one month.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Neurophysiology and Cognition in Children and Young Adults Lab, School and Graduate Institute of Physical Therapy of National Taiwan University (NTU-PT)
Taipei County, 100
About this study
The goal of this clinical trial is to investigate the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensity in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes in respect to executive functions.
The main questions it aims to answer are:
Read more
- To find out the effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD
- To examine the relationship between neurophysiology and executive functions following a single bout of aerobic exercise intervention
Participants will be asked to do three different executive function tasks regarding inhibitory control, working memory and cognitive planning and receive the evaluation of motor cortex excitability via transcranial magnetic stimulation (TMS) before and after a single bout of 30-min aerobic cycling exercise of moderate intensity. Researchers will compare the control group with 30-min video-watching to see if effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD.
Read the detailed description
Attention-deficit hyperactivity disorder (ADHD) is the most prevalent neuropsychiatric disorders affecting 5-10% of children worldwide (7~8% in Taiwan) characterized by a persistent pattern of inattention and/or hyperactivity/impulsivity. Recent survey estimated that around 57% of children with ADHD will continue to have persistent symptoms into adolescents and adulthood. Due to the dynamic neurocognitive development process, and the transition and formation of educational and social relationship, adolescents (13-17 years) represent critical periods in the phase of life. Emerging literature has proposed the main conditions of ADHD are related to cognitive function impairments such as inhibitory control, working memory and cognitive planning. These deficits disrupt educational process, harm academic and social functions, and seriously reduce quality of life for adolescents with ADHD.
Recently, noninvasive brain stimulation techniques are considered for investigating the neural mechanism of neurodevelopmental disorders including ADHD. Previous studies using transcranial magnetic stimulation (TMS) in combination with motor-evoked potentials (MEPs; muscle contraction in response to TMS) have reported deficits in specific inhibitory functions of the motor loop in ADHD. In line with this, our previous study found decreased intracortical inhibition and enhanced intracortical facilitation in ADHD subjects compared to healthy control (under review). These findings implied that ADHD causes stem from disturbances in large-scale brain networks Therefore, it is essential to understand the neurophysiological mechanism in ADHD, and furthermore develop effective interventions based on this foundation.
Aerobic exercise has been suggested as a safe and low-cost adjunctive therapy for ADHD and is known to have beneficial effects on cognition and behavioral performance in children and adolescents. The underlying mechanism depends at least partially on mechanisms of neuroplasticity. Animal data suggest that neuronal excitability is enhanced by aerobic exercise via suppressing gamma-aminobutyric acid (GABA)-ergic inhibition and facilitating the activation of N-methyl-D-aspartate (NMDA) receptors. Furthermore, aerobic exercise enhanced the induction of long-term potentiation (LTP) which is thought to play a key role in the cellular mechanisms of learning and memory. These findings align with human data. Our and other studies have shown that aerobic exercise can enhance cortical excitability via increasing intracortical facilitation and reducing inhibition in healthy subjects by TMS. At the cognitive domain, animal models have shown that aerobic exercise prominently affects diverse cognitive functions, including learning and memory. Similarly, in the human study, a single bout of light-intensity aerobic exercise promotes performance of a visuomotor accuracy-tracking task and verbal memory. Meta-analytic research has shown beneficial effects of moderate to vigorous-intensity aerobic exercise on cognitive performance in humans. Specific for ADHD population, previous results showed significant improvement in inhibitory control, speed of processing, and attention after acute aerobic exercise (30 mins cycling: a 5 min warm up, 20 min of core exercise, and a 5 min cool-down) at moderate intensity. Taken together, these studies suggest that impact of aerobic exercise might not restricted to motor domain. Additionally, the positive effects of aerobic exercise on cognitive processes and clinical outcomes might be caused by its mediating effects on neural mechanisms.
According to our research experienced, we are interested in the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensities in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes. Combined application of neurophysiological recording tools, including non-invasive brain stimulation, are suited to explore the impact of aerobic exercise on cortical physiology of motor and prefrontal cortex, and the functional association of cognition and clinical performance in humans. We will apply TMS to obtain evoked potentials recorded either with electromyography (EMG) or EEG to cortical excitability, also with regard to the contributions of specific transmitters and neuromodulators, such as glutamate and GABA, over task-relevant target areas such as motor and prefrontal cortex. Furthermore, we will combine cognitive task (e.g., inhibitory control, working memory and cognitive planning tasks) to explore the association between the neurophysiological effects of aerobic exercise and respective cognitive and clinical alterations. The study will be critically important in setting a conceptual framework for developing alternative treatment in ADHD, especially for aerobic exercise intervention. In addition, results of the study contribute to lay the ground work for both scientific and clinical application in adolescents with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Aerobic exercise, Video-watching
- Keywords
- Attention Deficit Hyperactivity Disorder, A single bout of aerobic exercise, Executive functions, Neurophysiology
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
The aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with HR at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise.
Video-watchingOther
The video-watching group will be asked to watch a nature documentary for 30 mins
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | The aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with heart rate (HR) at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise. Receives: Other: Aerobic exercise |
| Video-watching group | Active comparator | The video-watching group will be asked to watch a nature documentary for 30 mins Receives: Other: Video-watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop Signal Task (SST)
The test will require participants to respond to an arrow stimulus pointing in a given direction. The first set incorporates 16 trials where the participants practice the response. In the second set, the participants will be told to inhibit their response if they heard an auditory signal (a beep). An adaptive staircase will be employed for the stop signal delay allowing the task to adapt to the performance of the participant to result in a 50% success rate. An inter-stimulus interval of 1,000 ms will be applied. The outcome measures are the stop signal reaction time, the estimate of when an individual can successfully inhibit their response 50% of the time. This is inferred as the time before all actions become ballistic, and the person is no longer able to stop the action
Measured: Pre-intervention/immediately after the intervention
Spatial Working Memory (SWM) task
The SWM task is based on a self-ordered search test and assesses primarily nonverbal working memory. Participants are asked to search through a number of colored boxes presented on the screen to find a different token hidden inside. Each box housed only one token per trial. Searching a box more than once during a sequence resulted in within errors, and returning to an emptied box resulted in between errors. A double error could be categorized as both a within and a between error. Two major indices are presented: (1) strategy utilization: the number of search sequences starting with a novel box in both 6- and 8-box problems, and (2) errors in total and three different levels of difficulty (4-, 6-, and 8-box problems): the total errors were calculated as the sum of between errors and within errors minus double errors for searches.
Measured: Pre-intervention/immediately after the intervention
Stockings of Cambridge (SOC)
The SOC requires participants to plan and execute a set of movements to replicate a goal arrangement of balls. At the beginning of each trial, there are two displays shown on the screen simultaneously, and three suspended vertical stockings and three colored balls are presented. Participants are asked to move the colored balls in a single move at a time between the stockings, to correspond to a goal position shown in the top display within a specified number of moves (2, 3, 4, and 5 moves). In the control condition, they are required to follow the ball movements as quickly as possible to provide baseline measures of reaction and movement times, with each trial being an exact replication of their earlier planning moves. Three major indices are presented: (1) number of problems solved in the specified minimum number of moves; (2) mean moves: the number of moves taken in excess of the specified minimum number, but within the maximum allowed
Measured: Pre-intervention/immediately after the intervention
TMS parameters: Motor evoked potential (MEP)
TMS is applied with a figure-of-eight coil with an internal diameter of 70mm connected to a Magstim stimulator (Magstim, Whiteland, Dyfed, UK), which generates a strong, short-lasting magnetic stimulus. It induces an electric current flow in the motor cortex sufficient to activate neurons at the suprathreshold level, shown as MEP of the representational muscle. Surface MEPs is recorded from the right abductor digiti minimi muscle (ADM) with an Ag-AgCl electrode in a belly-tendon montage. The signals will be filtered (2Hz to 2 kHz, sampling rate 5 kHz), amplified, and then stored on a computer via a Power 1401 data acquisition interface (Cambridge Electronic Design, Cambridge, UK).
The peak-to-peak amplitude of the MEP is defined as the overall response of the ADM induced by stimulating the contralateral motor cortex by TMS. The mean MEP is averaged in at least 15 trials and recorded as milli voltage.
Measured: Pre-intervention/immediately after the intervention
TMS parameters: Resting motor threshold (RMT)
RMT is defined as the minimum TMS intensity that elicits a peak-to-peak MEP of 50~100 microvoltage (μV) in the relaxed muscle in at least three of six consecutive trials. RMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit RMT.
Measured: Pre-intervention/immediately after the intervention
TMS parameters: Active motor threshold (AMT)
AMT is the minimum intensity eliciting an MEP response of 200~300 microvoltage (μV) during moderate spontaneous background muscle activity (~15% of the maximum muscle strength) in at least three of six consecutive trials. AMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit AMT.
Measured: Pre-intervention/immediately after the intervention
TMS parameters: Short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF)
In the SICI-ICF protocol, a subthreshold conditioning stimulus (determined as 70 % of AMT) precedes the test stimulus (determined as baseline MEP of ~1mV) with the interstimulus intervals (ISIs) of 2, 3, 5, 10, and 15ms. The first three ISIs reflect inhibitory and the last two ISIs reveal facilitatory effects. The pairs of stimuli are organized into 15 blocks. Each block contains double pulses with all ISIs, and one additional single test pulse in a pseudo-randomized order for each block. SICI is mainly influenced by GABAA receptors and ICF is thought to predominantly reflect the activity of the glutamatergic system, with some GABAA contribution. The SICI-ICF is presented as the subtraction of the conditioning stimulus by the test stimulus.
Measured: Pre-intervention/immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start9 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-I Kuo, Ph.D., Principal investigator, NTUPT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129396
- Sponsor's protocol ID
- 202211047RIND
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06129396
- Acronym / sponsor ID
- 202211047RIND
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, A single bout of aerobic exercise, Executive functions, Neurophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Nov 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.
The goal of this clinical trial is to investigate the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensity in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes in respect to executive functions.
The main questions it aims to answer are:
- To find out the effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD
- To examine the relationship between neurophysiology and executive functions following a single bout of aerobic exercise intervention
Participants will be asked to do three different executive function tasks regarding inhibitory control, working memory and cognitive planning and receive the evaluation of motor cortex excitability via transcranial magnetic stimulation (TMS) before and after a single bout of 30-min aerobic cycling exercise of moderate intensity. Researchers will compare the control group with 30-min video-watching to see if effects of a single bout of aerobic exercise intervention on neurophysiology and executive functions in adolescents with ADHD.
Detailed description
Attention-deficit hyperactivity disorder (ADHD) is the most prevalent neuropsychiatric disorders affecting 5-10% of children worldwide (7~8% in Taiwan) characterized by a persistent pattern of inattention and/or hyperactivity/impulsivity. Recent survey estimated that around 57% of children with ADHD will continue to have persistent symptoms into adolescents and adulthood. Due to the dynamic neurocognitive development process, and the transition and formation of educational and social relationship, adolescents (13-17 years) represent critical periods in the phase of life. Emerging literature has proposed the main conditions of ADHD are related to cognitive function impairments such as inhibitory control, working memory and cognitive planning. These deficits disrupt educational process, harm academic and social functions, and seriously reduce quality of life for adolescents with ADHD.
Recently, noninvasive brain stimulation techniques are considered for investigating the neural mechanism of neurodevelopmental disorders including ADHD. Previous studies using transcranial magnetic stimulation (TMS) in combination with motor-evoked potentials (MEPs; muscle contraction in response to TMS) have reported deficits in specific inhibitory functions of the motor loop in ADHD. In line with this, our previous study found decreased intracortical inhibition and enhanced intracortical facilitation in ADHD subjects compared to healthy control (under review). These findings implied that ADHD causes stem from disturbances in large-scale brain networks Therefore, it is essential to understand the neurophysiological mechanism in ADHD, and furthermore develop effective interventions based on this foundation.
Aerobic exercise has been suggested as a safe and low-cost adjunctive therapy for ADHD and is known to have beneficial effects on cognition and behavioral performance in children and adolescents. The underlying mechanism depends at least partially on mechanisms of neuroplasticity. Animal data suggest that neuronal excitability is enhanced by aerobic exercise via suppressing gamma-aminobutyric acid (GABA)-ergic inhibition and facilitating the activation of N-methyl-D-aspartate (NMDA) receptors. Furthermore, aerobic exercise enhanced the induction of long-term potentiation (LTP) which is thought to play a key role in the cellular mechanisms of learning and memory. These findings align with human data. Our and other studies have shown that aerobic exercise can enhance cortical excitability via increasing intracortical facilitation and reducing inhibition in healthy subjects by TMS. At the cognitive domain, animal models have shown that aerobic exercise prominently affects diverse cognitive functions, including learning and memory. Similarly, in the human study, a single bout of light-intensity aerobic exercise promotes performance of a visuomotor accuracy-tracking task and verbal memory. Meta-analytic research has shown beneficial effects of moderate to vigorous-intensity aerobic exercise on cognitive performance in humans. Specific for ADHD population, previous results showed significant improvement in inhibitory control, speed of processing, and attention after acute aerobic exercise (30 mins cycling: a 5 min warm up, 20 min of core exercise, and a 5 min cool-down) at moderate intensity. Taken together, these studies suggest that impact of aerobic exercise might not restricted to motor domain. Additionally, the positive effects of aerobic exercise on cognitive processes and clinical outcomes might be caused by its mediating effects on neural mechanisms.
According to our research experienced, we are interested in the neurophysiological foundation of the impact of the acute effects of controlled aerobic exercise intensities in adolescents with ADHD, its involvement in cognitive processes, and clinical outcomes. Combined application of neurophysiological recording tools, including non-invasive brain stimulation, are suited to explore the impact of aerobic exercise on cortical physiology of motor and prefrontal cortex, and the functional association of cognition and clinical performance in humans. We will apply TMS to obtain evoked potentials recorded either with electromyography (EMG) or EEG to cortical excitability, also with regard to the contributions of specific transmitters and neuromodulators, such as glutamate and GABA, over task-relevant target areas such as motor and prefrontal cortex. Furthermore, we will combine cognitive task (e.g., inhibitory control, working memory and cognitive planning tasks) to explore the association between the neurophysiological effects of aerobic exercise and respective cognitive and clinical alterations. The study will be critically important in setting a conceptual framework for developing alternative treatment in ADHD, especially for aerobic exercise intervention. In addition, results of the study contribute to lay the ground work for both scientific and clinical application in adolescents with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Other: Aerobic exerciseThe aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with heart rate (HR) at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise. |
| Video-watching group | Active comparator | Other: Video-watchingThe video-watching group will be asked to watch a nature documentary for 30 mins |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of ADHD by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- Adolescents aged between 13-17
- Absence of other neuropsychological disorders including, autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
- Right-handed
Key exclusion criteria (5 listed)
- Presence of other major systematical diseases
- Taking neuropsychological medication within one month, except for medication for ADHD
- With contraindications for non-invasive brain stimulation such as epilepsy, pacemaker or intracranial mental implants
- Color blindness
- Taking part in other studies within one month.
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 |
|---|---|---|
| Aerobic exerciseThe aerobic exercise consists of: (1) 5 min warm-up exercise, (2) 20 min aerobic exercise with HR at target zone (one research assistant will be onsite to monitor whether the HR is around the range of moderate intensity), and (3) 5 min cool-down exercise. | Other | Aerobic exercise group |
| Video-watchingThe video-watching group will be asked to watch a nature documentary for 30 mins | Other | Video-watching group |
Primary outcome
Stop Signal Task (SST)
Time frame: Pre-intervention/immediately after the intervention
The test will require participants to respond to an arrow stimulus pointing in a given direction. The first set incorporates 16 trials where the participants practice the response. In the second set, the participants will be told to inhibit their response if they heard an auditory signal (a beep). An adaptive staircase will be employed for the stop signal delay allowing the task to adapt to the performance of the participant to result in a 50% success rate. An inter-stimulus interval of 1,000 ms will be applied. The outcome measures are the stop signal reaction time, the estimate of when an individual can successfully inhibit their response 50% of the time. This is inferred as the time before all actions become ballistic, and the person is no longer able to stop the action
Spatial Working Memory (SWM) task
Time frame: Pre-intervention/immediately after the intervention
The SWM task is based on a self-ordered search test and assesses primarily nonverbal working memory. Participants are asked to search through a number of colored boxes presented on the screen to find a different token hidden inside. Each box housed only one token per trial. Searching a box more than once during a sequence resulted in within errors, and returning to an emptied box resulted in between errors. A double error could be categorized as both a within and a between error. Two major indices are presented: (1) strategy utilization: the number of search sequences starting with a novel box in both 6- and 8-box problems, and (2) errors in total and three different levels of difficulty (4-, 6-, and 8-box problems): the total errors were calculated as the sum of between errors and within errors minus double errors for searches.
Stockings of Cambridge (SOC)
Time frame: Pre-intervention/immediately after the intervention
The SOC requires participants to plan and execute a set of movements to replicate a goal arrangement of balls. At the beginning of each trial, there are two displays shown on the screen simultaneously, and three suspended vertical stockings and three colored balls are presented. Participants are asked to move the colored balls in a single move at a time between the stockings, to correspond to a goal position shown in the top display within a specified number of moves (2, 3, 4, and 5 moves). In the control condition, they are required to follow the ball movements as quickly as possible to provide baseline measures of reaction and movement times, with each trial being an exact replication of their earlier planning moves. Three major indices are presented: (1) number of problems solved in the specified minimum number of moves; (2) mean moves: the number of moves taken in excess of the specified minimum number, but within the maximum allowed
TMS parameters: Motor evoked potential (MEP)
Time frame: Pre-intervention/immediately after the intervention
TMS is applied with a figure-of-eight coil with an internal diameter of 70mm connected to a Magstim stimulator (Magstim, Whiteland, Dyfed, UK), which generates a strong, short-lasting magnetic stimulus. It induces an electric current flow in the motor cortex sufficient to activate neurons at the suprathreshold level, shown as MEP of the representational muscle. Surface MEPs is recorded from the right abductor digiti minimi muscle (ADM) with an Ag-AgCl electrode in a belly-tendon montage. The signals will be filtered (2Hz to 2 kHz, sampling rate 5 kHz), amplified, and then stored on a computer via a Power 1401 data acquisition interface (Cambridge Electronic Design, Cambridge, UK). The peak-to-peak amplitude of the MEP is defined as the overall response of the ADM induced by stimulating the contralateral motor cortex by TMS. The mean MEP is averaged in at least 15 trials and recorded as milli voltage.
TMS parameters: Resting motor threshold (RMT)
Time frame: Pre-intervention/immediately after the intervention
RMT is defined as the minimum TMS intensity that elicits a peak-to-peak MEP of 50~100 microvoltage (μV) in the relaxed muscle in at least three of six consecutive trials. RMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit RMT.
TMS parameters: Active motor threshold (AMT)
Time frame: Pre-intervention/immediately after the intervention
AMT is the minimum intensity eliciting an MEP response of 200~300 microvoltage (μV) during moderate spontaneous background muscle activity (~15% of the maximum muscle strength) in at least three of six consecutive trials. AMT is recorded by the intensity of TMS presented by percentage (0-100%). The higher percentage represents a stronger intensity to elicit AMT.
TMS parameters: Short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF)
Time frame: Pre-intervention/immediately after the intervention
In the SICI-ICF protocol, a subthreshold conditioning stimulus (determined as 70 % of AMT) precedes the test stimulus (determined as baseline MEP of ~1mV) with the interstimulus intervals (ISIs) of 2, 3, 5, 10, and 15ms. The first three ISIs reflect inhibitory and the last two ISIs reveal facilitatory effects. The pairs of stimuli are organized into 15 blocks. Each block contains double pulses with all ISIs, and one additional single test pulse in a pseudo-randomized order for each block. SICI is mainly influenced by GABAA receptors and ICF is thought to predominantly reflect the activity of the glutamatergic system, with some GABAA contribution. The SICI-ICF is presented as the subtraction of the conditioning stimulus by the test stimulus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Hsiao-I Kuo, Ph.D. principal investigator
NTUPT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Video-watching in people with Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-I Kuo, Ph.D. (02-33668137, hikuo@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop Signal Task (SST) (time frame: Pre-intervention/immediately after the intervention). The study lists 7 primary outcomes in all. 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 13 Nov 2023.