Stroke, ChronicAMPLIFINCT06950060
AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions
A study testing High intensity cycling, Low-intensity cycling and Health education session in people with Stroke, Chronic and Aging, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Chronic, Aging, Cognitive Decline
- What is being tested?
- High intensity cycling, Low-intensity cycling and Health education session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For All Participants:
- Able to provide informed consent
- Right-handed (for TMS consistency)
- English-speaking
- Clearance for moderate-intensity aerobic exercise
- Able to safely sit and pedal a stationary cycle ergometer
Show all 18Show fewer
- No contraindications to TMS (e.g., no metal in skull, pacemakers, or seizure history)
- Younger Adults (18-35):
- No history of neurological or psychiatric conditions
- Not currently on medications that affect the central nervous system
- Older Adults (60-85):
- No diagnosis of dementia
- Independent in activities of daily living
- No stroke history
- Stroke Survivors (40-85):
- At least 6 months post-stroke (chronic phase)
- Medically stable and cleared for aerobic exercise
- Able to engage in motor learning task (with or without hemiparetic adaptations)
Who cannot join
- History of epilepsy or seizures
- Current substance abuse or uncontrolled psychiatric disorder
- Severe cardiovascular disease or unstable medical condition
- Pregnancy
- Contraindications to TMS or exercise testing (e.g., implanted neurostimulators, severe hypertension)
- Participation in another interventional trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. The study compares three groups: one performing aerobic cycling at an intensity that elevates lactate levels, one performing low-intensity exercise, and one receiving health education without exercise.
All participants will complete motor learning tasks and undergo brain-stimulation testing using transcranial magnetic stimulation (TMS) to assess how well the brain responds to training. The goal is to understand whether different types of exercise can improve brain function, movement, and memory, and how the body's response to exercise (like lactate levels) might support brain health.
This research may help identify low-cost, non-invasive interventions-such as targeted exercise-that improve motor and cognitive outcomes in aging and stroke recovery.
Read the detailed description
The AMPLIFI study is a mechanistic clinical trial designed to investigate the neurophysiological effects of acute aerobic exercise on cortical plasticity and motor learning in older adults and individuals with chronic stroke. Participants are randomized into one of three groups: (1) moderate-to-high intensity aerobic exercise at lactate threshold, (2) moderate intensity aerobic exercise, (3) low-intensity aerobic exercise, or (4) education-only control.
The primary outcome measure is cortical inhibition, assessed using transcranial magnetic stimulation (TMS) measures including short-interval intracortical inhibition (SICI), long-interval intracortical inhibition (LICI), and intracortical facilitation (ICF). Secondary outcomes include performance on upper extremity motor tasks, measures of verbal and executive function, and blood lactate levels.
Participants complete three sessions over 2-3 weeks, including baseline assessments, VO2 max testing, multiple blood draws, and cognitive and motor testing. The exercise intervention is delivered via stationary cycling at intensities tailored using individual VO2 max data and lactate monitoring. Genetic and biochemical assays will be performed on blood samples to explore associations between metabolic and neural response.
This study will clarify how lactate-related exercise intensity impacts cortical inhibition and whether those effects support improvements in motor learning. Findings may help define the mechanisms by which exercise promotes neuroplasticity and support individualized rehabilitation strategies for aging and post-stroke populations.
- Conditions
- Stroke, Chronic, Aging, Cognitive Decline, Motor Dysfunction, Neuroplasticity
- Being tested
- High intensity cycling, Low-intensity cycling, Health education session, Moderate Intensity Aerobic Exercise
- Keywords
- Transcranial Magnetic Stimulation (TMS), Cortical Inhibition, Neuroplasticity, Aerobic Exercise, Motor Learning, Aging, Stroke Rehabilitation, Cortical Excitability, GABAergic Inhibition
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome, Cognitive Dysfunction, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity cyclingBehavioural
Also called HIIT
Participants cycle on a stationary ergometer at an intensity prescribed to reach their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of exercise-induced metabolic stress on cortical inhibition and motor learning.
Low-intensity cyclingBehavioural
Also called MICT
Participants perform 20 minutes of cycling at a light workload below their lactate threshold. Exercise intensity is individualized using heart rate and perceived exertion (Borg RPE scale), avoiding significant metabolic activation. TMS and motor learning are assessed pre- and post-exercise. This condition serves as an active comparator to assess the impact of exercise intensity.
Health education sessionBehavioural
Also called Education
Participants receive a 20-minute session of health education content (e.g., wellness, healthy aging). No exercise is performed. Participants undergo TMS and motor learning testing before and after the session. This condition is used to control for attention and cognitive engagement without physical activity.
Moderate Intensity Aerobic ExerciseBehavioural
Participants cycle on a stationary ergometer at an intensity prescribed to surround, but not exceed their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of moderate exercise-induced metabolic stress on cortical inhibition and motor learning.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise at Lactate Threshold | Experimental | Participants complete a 20-minute aerobic cycling session at individually prescribed intensity to achieve lactate threshold, based on VO2 max and blood lactate data. This condition is designed to induce metabolic stress and engage neuromodulatory pathways related to cortical plasticity. Participants complete TMS and motor learning tasks before and after the intervention. Receives: Behavioral: High intensity cycling |
| Low-Intensity Aerobic Exercise | Active comparator | Participants complete a 20-minute cycling session at a light workload, below lactate threshold. This condition controls for movement and engagement without significant metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention. Receives: Behavioral: Low-intensity cycling |
| Education Control | Placebo comparator | Participants engage in a 20-minute health education session instead of exercise. This arm serves as a non-exercise control to isolate the effects of physical exertion on neuroplasticity. All outcome measures are collected similarly to the exercise groups. Receives: Behavioral: Health education session |
| Active Comparator: Moderate-Intensity Aerobic Exercise | Active comparator | Arm Description: Participants complete a 20-minute cycling session at a moderate workload, surrounding lactate threshold. This condition controls for movement and engagement without advanced metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention. Receives: Behavioral: Moderate Intensity Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Learning Performance (12-Digit Serial Reaction Time Task)
Motor learning is assessed using the 12-digit Serial Reaction Time Task (SRTT), a computer-based measure of implicit motor sequence learning. Participants respond to visual cues by pressing buttons in a fixed or random sequence. Learning is quantified by changes in reaction time and accuracy across structured and unstructured trials. A learning index is derived by comparing performance between patterned (learning) and random sequences.
Measured: Baseline, Day 2, Day 3, Day 4, and Day 5
Secondary outcomes (4)
Change in Long-Interval Intracortical Inhibition (LICI)
LICI is measured using a 100 ms interstimulus interval to assess GABA<sub>B</sub>-mediated inhibition. Recorded before and after each intervention session.
Measured: Baseline, Day 5
Change in Intracortical Facilitation (ICF)
ICF is assessed using paired-pulse TMS with a 10-15 ms interstimulus interval to evaluate cortical excitability.
Measured: Baseline, Day 5
Change in Blood Lactate Concentration
Measured via fingerstick blood samples pre-, mid-, and post-exercise.
Measured: Day 2, Day 3, Day 4
Change in Executive Function (D-KEFS Verbal Fluency and Stroop Tests)
Executive function neuropsychological tests.
Measured: Day 1 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start15 Jul 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, ChronicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of four parallel groups: (1) aerobic exercise at lactate threshold, (2) moderate intensity exercise, (3) low-intensity aerobic exercise, or (4) education-only control. Outcomes are assessed at multiple time points to examine changes in cortical inhibition, motor performance, and cognitive function.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith McGregor, University of Alabama at Birmingham
- Investigators
- Keith McGregor, PhD, Principal investigator, Keith McGregor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950060
- Sponsor's protocol ID
- IRB-300014361
- Acronym
- AMPLIFI
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, not beyond the original research team.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions
- ClinicalTrials.gov ID
- NCT06950060
- Acronym / sponsor ID
- AMPLIFI / IRB-300014361
- Conditions
- Stroke, Chronic, Aging, Cognitive Decline, Motor Dysfunction, Neuroplasticity
- Keywords
- Transcranial Magnetic Stimulation (TMS), Cortical Inhibition, Neuroplasticity, Aerobic Exercise, Motor Learning, Aging, Stroke Rehabilitation, Cortical Excitability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Apr 2025 (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 AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. The study compares three groups: one performing aerobic cycling at an intensity that elevates lactate levels, one performing low-intensity exercise, and one receiving health education without exercise.
All participants will complete motor learning tasks and undergo brain-stimulation testing using transcranial magnetic stimulation (TMS) to assess how well the brain responds to training. The goal is to understand whether different types of exercise can improve brain function, movement, and memory, and how the body's response to exercise (like lactate levels) might support brain health.
This research may help identify low-cost, non-invasive interventions-such as targeted exercise-that improve motor and cognitive outcomes in aging and stroke recovery.
Detailed description
The AMPLIFI study is a mechanistic clinical trial designed to investigate the neurophysiological effects of acute aerobic exercise on cortical plasticity and motor learning in older adults and individuals with chronic stroke. Participants are randomized into one of three groups: (1) moderate-to-high intensity aerobic exercise at lactate threshold, (2) moderate intensity aerobic exercise, (3) low-intensity aerobic exercise, or (4) education-only control.
The primary outcome measure is cortical inhibition, assessed using transcranial magnetic stimulation (TMS) measures including short-interval intracortical inhibition (SICI), long-interval intracortical inhibition (LICI), and intracortical facilitation (ICF). Secondary outcomes include performance on upper extremity motor tasks, measures of verbal and executive function, and blood lactate levels.
Participants complete three sessions over 2-3 weeks, including baseline assessments, VO2 max testing, multiple blood draws, and cognitive and motor testing. The exercise intervention is delivered via stationary cycling at intensities tailored using individual VO2 max data and lactate monitoring. Genetic and biochemical assays will be performed on blood samples to explore associations between metabolic and neural response.
This study will clarify how lactate-related exercise intensity impacts cortical inhibition and whether those effects support improvements in motor learning. Findings may help define the mechanisms by which exercise promotes neuroplasticity and support individualized rehabilitation strategies for aging and post-stroke populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are randomized into one of four parallel groups: (1) aerobic exercise at lactate threshold, (2) moderate intensity exercise, (3) low-intensity aerobic exercise, or (4) education-only control. Outcomes are assessed at multiple time points to examine changes in cortical inhibition, motor performance, and cognitive function.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise at Lactate Threshold | Experimental | Behavioral: High intensity cyclingParticipants complete a 20-minute aerobic cycling session at individually prescribed intensity to achieve lactate threshold, based on VO2 max and blood lactate data. This condition is designed to induce metabolic stress and engage neuromodulatory pathways related to cortical plasticity. Participants complete TMS and motor learning tasks before and after the intervention. |
| Low-Intensity Aerobic Exercise | Active comparator | Behavioral: Low-intensity cyclingParticipants complete a 20-minute cycling session at a light workload, below lactate threshold. This condition controls for movement and engagement without significant metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention. |
| Education Control | Placebo comparator | Behavioral: Health education sessionParticipants engage in a 20-minute health education session instead of exercise. This arm serves as a non-exercise control to isolate the effects of physical exertion on neuroplasticity. All outcome measures are collected similarly to the exercise groups. |
| Active Comparator: Moderate-Intensity Aerobic Exercise | Active comparator | Behavioral: Moderate Intensity Aerobic ExerciseArm Description: Participants complete a 20-minute cycling session at a moderate workload, surrounding lactate threshold. This condition controls for movement and engagement without advanced metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Able to provide informed consent
- Right-handed (for TMS consistency)
- English-speaking
- Clearance for moderate-intensity aerobic exercise
- Able to safely sit and pedal a stationary cycle ergometer
Key exclusion criteria (6 listed)
- History of epilepsy or seizures
- Current substance abuse or uncontrolled psychiatric disorder
- Severe cardiovascular disease or unstable medical condition
- Pregnancy
- Contraindications to TMS or exercise testing (e.g., implanted neurostimulators, severe hypertension)
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 |
|---|---|---|
| High intensity cyclingAlso: HIITParticipants cycle on a stationary ergometer at an intensity prescribed to reach their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of exercise-induced metabolic stress on cortical inhibition and motor learning. | Behavioural | Aerobic Exercise at Lactate Threshold |
| Low-intensity cyclingAlso: MICTParticipants perform 20 minutes of cycling at a light workload below their lactate threshold. Exercise intensity is individualized using heart rate and perceived exertion (Borg RPE scale), avoiding significant metabolic activation. TMS and motor learning are assessed pre- and post-exercise. This condition serves as an active comparator to assess the impact of exercise intensity. | Behavioural | Low-Intensity Aerobic Exercise |
| Health education sessionAlso: EducationParticipants receive a 20-minute session of health education content (e.g., wellness, healthy aging). No exercise is performed. Participants undergo TMS and motor learning testing before and after the session. This condition is used to control for attention and cognitive engagement without physical activity. | Behavioural | Education Control |
| Moderate Intensity Aerobic ExerciseParticipants cycle on a stationary ergometer at an intensity prescribed to surround, but not exceed their lactate threshold, guided by VO2 max results and lactate sampling. The session lasts approximately 20 minutes and is preceded and followed by TMS assessments and a structured motor learning task. This condition is designed to evaluate the effect of moderate exercise-induced metabolic stress on cortical inhibition and motor learning. | Behavioural | Active Comparator: Moderate-Intensity Aerobic Exercise |
Primary outcome
Motor Learning Performance (12-Digit Serial Reaction Time Task)
Time frame: Baseline, Day 2, Day 3, Day 4, and Day 5
Motor learning is assessed using the 12-digit Serial Reaction Time Task (SRTT), a computer-based measure of implicit motor sequence learning. Participants respond to visual cues by pressing buttons in a fixed or random sequence. Learning is quantified by changes in reaction time and accuracy across structured and unstructured trials. A learning index is derived by comparing performance between patterned (learning) and random sequences.
4 secondary outcomes
Change in Long-Interval Intracortical Inhibition (LICI)
Time frame: Baseline, Day 5
Change in Intracortical Facilitation (ICF)
Time frame: Baseline, Day 5
Change in Blood Lactate Concentration
Time frame: Day 2, Day 3, Day 4
Change in Executive Function (D-KEFS Verbal Fluency and Stroop Tests)
Time frame: Day 1 and Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. No, not beyond the original research team.
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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.
Keith McGregor, PhD principal investigator
Keith McGregor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity cycling, Low-intensity cycling and Health education session in people with Stroke, Chronic and Aging, run by University of Alabama at Birmingham at 1 site in United States.
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 18 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 Learning Performance (12-Digit Serial Reaction Time Task) (time frame: Baseline, Day 2, Day 3, Day 4, and Day 5). 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 17 Jul 2026.