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AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions

Noch nicht rekrutierend
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Die klinische Studie NCT06950060 (AMPLIFI) ist eine interventionsstudie zur Untersuchung von Stroke, Chronic, Altern, Kognitiver Abbau, Motor Dysfunction, Neuroplastizität und hat den Status noch nicht rekrutierend. Der Start ist für 30. September 2025 geplant, bis 48 Teilnehmer aufgenommen werden. Durchgeführt von Universität von Alabama in Birmingham wird der Abschluss für 1. Januar 2030 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. Juli 2025 aktualisiert.
Kurzbeschreibung
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 exercise at an intensity that increases lactate levels, one doing 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, or 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.

Ausführliche Beschreibung
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) low-intensity aerobic exercise, or (3) education-only control. A crossover component allows each participant to undergo both exercise and motor learning-only conditions on separate days, with condition order randomized.

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 five 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.

Offizieller Titel

AMPLIFI: Adaptive Modulation of Plasticity Through Lactate and Fitness Interventions

Erkrankungen
Stroke, ChronicAlternKognitiver AbbauMotor DysfunctionNeuroplastizität
Weitere Studien-IDs
  • AMPLIFI
  • IRB-300014361
NCT-Nummer
Studienbeginn (tatsächlich)
2025-09-30
Zuletzt aktualisiert
2025-07-08
Studienende (vorauss.)
2030-01-01
Geplante Rekrutierung
48
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Transcranial Magnetic Stimulation (TMS)
Cortical Inhibition
Neuroplasticity
Aerobic Exercise
Motor Learning
Aging
Stroke Rehabilitation
Cortical Excitability
GABAergic Inhibition
Primäres Ziel
Grundlagenforschung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellAerobic Exercise at Lactate Threshold
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.
Moderate-to-high Intensity Cycling
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.
Aktives VergleichspräparatLow-Intensity Aerobic Exercise
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.
Low-intensity Cycling
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.
Placebo-VergleichspräparatEducation Control
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.
Health Education Session
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Baseline, Day 2, Day 3, Day 4, and Day 5
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
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.
Baseline, Day 5
Change in Blood Lactate Concentration
Measured via fingerstick blood samples pre-, mid-, and post-exercise.
Day 2, Day 3, Day 4
Change in Executive Function (D-KEFS Verbal Fluency and Stroop Tests)
Executive function neuropsychological tests.
Day 1 and Day 5
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja

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
  • 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 (18-85):

  • 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)

  • 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
University of Alabama at Birmingham logoUniversität von Alabama in Birmingham493 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Keith McGregor, Hauptprüfer, Associate Professor, Director of Research, University of Alabama at Birmingham
Zentrale Studienkontakte
Kontakt: Keith M McGregor, PhD, ‪(205) 693-9997‬, [email protected]
Kontakt: Sarah Bruton, BS, ‪(205) 693-9997‬, [email protected]
1 Studienstandorte in 1 Ländern

Alabama

CH19 933 19th St S, Birmingham, Alabama, 35233, United States
Keith M McGregor, PhD, Kontakt, ‪(205) 693-9997‬, [email protected]
Sarah Bruton, BS, Kontakt, ‪(205) 693-9997‬, [email protected]
Keith M McGregor, PhD, Hauptprüfer