AgingNCT07901322
Cerebello-Cortical Connectivity and Balance Adaptation in Younger and Older Adults
A study testing Transcranial Magnetic Stimulation Assessment and Reactive Balance Adaptation Task in people with Aging and Postural Balance, run by University of Minnesota at 1 site in United States.
Trial summary
This study will investigate how communication between the cerebellum and cerebral cortex contributes to balance control and adaptation in younger and older adults. The study will enroll healthy younger adults ages 21-35 years and older adults ages 65-95 years. Read more about this study
- Who is it for?
- Ages 21 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Postural Balance, Motor Adaptation
- What is being tested?
- Transcranial Magnetic Stimulation Assessment and Reactive Balance Adaptation Task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2028
- 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 21 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 21-35 years (younger adult group) or 65-95 years (older adult group).
- Willing and able to participate in and comply with all study procedures.
- Able to provide informed consent and communicate with study researchers.
- English-speaking.
- No major orthopedic disability.
- Vision of 20/40 or better, with or without corrective lenses, by self-report.
- Able to stand for 10 minutes and walk 10 meters with or without an assistive device, without assistance from another person.
Who cannot join
- History of seizure, epilepsy, or convulsion in the participant or an immediate family member.
- Current use of antiepileptic medications.
- Metal or electrical implant in the head, neck, or chest, other than dental work.
- Any other contraindication identified on the TMS safety screening form.
- Pregnancy.
- Neurological diagnosis including stroke, Parkinson's disease, multiple sclerosis, Alzheimer's disease, cerebellar ataxia, or other progressive movement disorders.
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- Insulin-dependent diabetes.
- Peripheral neuropathy.
- Significant sensory impairment affecting balance or cognition, including visual, vestibular, or auditory impairment.
- Active dermatitis, infection, or open wounds on the head or scalp.
- Head injury or concussion within the previous year.
- Lower-extremity joint replacement or major orthopedic surgery within the previous year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota - Brains in Motion Laboratory, 426 Church Street SE, Room 219, Children's Rehabilitation Center
Minneapolis, Minnesota, 55455
Jacqueline Palmer, PT, DPT, PhD, 612-626-4364, brainsinmotion@umn.edu
About this study
Official title: Cerebello-cortical Connectivity as an Adaptive Mechanism for Balance Control With Aging
This study will investigate how communication between the cerebellum and cerebral cortex contributes to balance control and adaptation in younger and older adults.
The study will enroll healthy younger adults ages 21-35 years and older adults ages 65-95 years. Participants will complete a single testing session that includes clinical balance assessments, transcranial magnetic stimulation (TMS), electroencephalography (EEG), electromyography (EMG), and reactive balance testing using an instrumented treadmill.
Cerebello-cortical connectivity will be measured before and after reactive balance testing using cerebellar brain inhibition (CBI) and the cerebellar TMS-evoked potential P80. The study will examine how these measures relate to cortical activity, balance recovery, and adaptation across repeated perturbations, and whether these relationships differ between younger and older adults.
Read the detailed description
Age-related changes in brain structure and function can contribute to declines in balance and mobility. The cerebellum may play an important role in maintaining balance and supporting motor adaptation during aging, but the neurophysiological mechanisms underlying cerebello-cortical connectivity and reactive balance control remain incompletely understood.
This single-site, single-session basic experimental study will investigate cerebello-cortical connectivity and its relationship to reactive balance control in younger and older adults. The study will recruit younger adults ages 21-35 years and older adults ages 65-95 years, with a target of 24 participants with usable primary data in each age group and an allowance for additional enrollment.
Participants will complete one laboratory visit lasting approximately three hours. The session will include screening, clinical balance and mobility assessments, instrumentation for EEG and EMG recording, pre-balance cerebellar TMS assessment, reactive balance testing, and post-balance cerebellar TMS assessment.
Cerebello-cortical connectivity will be assessed using dual-site paired-pulse TMS to measure cerebellar brain inhibition (CBI) of the primary motor cortex and cerebellar TMS-EEG to measure the P80 potential over the prefrontal cortex. These measures will be collected before and after the reactive balance session.
Reactive balance testing will be performed on an instrumented treadmill that delivers support-surface translations. Initial perturbations will determine each participant's reactive step threshold. Participants will then complete repeated perturbations to assess cortical responses, biomechanical stability, and balance adaptation. An overhead safety harness and trained research staff will provide support throughout testing.
Secondary assessments will include cortical coherence, the perturbation-evoked N1 response, biomechanical stability margin, gait speed, clinical balance performance, and cognitive dual-task balance. The study will examine whether cerebello-cortical connectivity mediates relationships between cortical activity and balance performance and whether changes in connectivity following balance adaptation differ by age group.
TMS is used solely as a non-invasive research measurement method and is not administered as a therapeutic intervention.
- Conditions
- Aging, Postural Balance, Motor Adaptation
- Being tested
- Transcranial Magnetic Stimulation Assessment, Reactive Balance Adaptation Task
- Keywords
- Cerebello-cortical connectivity, Cerebellar brain inhibition, Electroencephalography, Transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation AssessmentDevice
Also called Magstim BiStim²
Single-pulse and paired-pulse transcranial magnetic stimulation will be delivered using a Magstim BiStim² stimulator and compatible coils to assess cerebello-cortical excitability. Dual-site TMS will be used to assess cerebellar brain inhibition, and cerebellar TMS combined with EEG will be used to assess the P80 TMS-evoked potential. Measurements will be collected before and after reactive balance testing. TMS is used as a research measurement procedure, not as a therapeutic intervention.
Reactive Balance Adaptation TaskBehavioural
Also called Support-Surface Perturbation Testing
Participants will complete a single session of reactive balance testing on an instrumented treadmill. Support-surface translations of varying magnitude will first be delivered to determine the reactive step threshold, followed by repeated perturbations at a fixed magnitude to evaluate balance recovery and adaptation. Participants will wear an overhead safety harness, and trained research personnel will supervise all testing.
| Study group | Role | What they receive |
|---|---|---|
| Reactive Balance and Cerebello-Cortical Connectivity Assessment | Experimental | All participants will undergo clinical balance assessments followed by transcranial magnetic stimulation (TMS) and TMS-EEG measurements before and after a single session of reactive balance testing. Reactive balance testing will involve support-surface perturbations delivered using an instrumented treadmill. Younger and older adults will undergo the same procedures, allowing comparison of cerebello-cortical connectivity and balance adaptation between age groups. Receives: Device: Transcranial Magnetic Stimulation Assessment; Behavioral: Reactive Balance Adaptation Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebellar Brain Inhibition (CBI) Ratio
Cerebellar brain inhibition will be assessed using dual-site, paired-pulse transcranial magnetic stimulation and EMG recordings from the right tibialis anterior muscle. The CBI ratio will be calculated as the mean conditioned peak-to-peak motor-evoked potential amplitude divided by the mean single-pulse motor-evoked potential amplitude for each interstimulus interval. Lower ratios indicate stronger cerebellar inhibition.
Measured: Before and after the reactive balance session, during a single study visit (up to 3 hours).
Change in Cerebellar TMS-Evoked Potential P80 Amplitude
The cerebellar TMS-evoked potential P80 will be measured using cerebellar TMS combined with EEG. P80 amplitude will be quantified as the peak EEG potential recorded over the contralateral dorsolateral prefrontal cortex within the 50-90 millisecond interval following TMS. Pre- and post-balance measurements will be compared.
Measured: Before and after the reactive balance session, during a single study visit (up to 3 hours).
Secondary outcomes (8)
Cortical Coherence During Reactive Balance Recovery
Perturbation-evoked EEG coherence between S1-M1 and PFC-M1 regions.
Measured: During the reactive balance testing session, up to 30 minutes
Cortical N1 Response and Adaptation
Perturbation-evoked EEG N1 response and its adaptation across repeated perturbations.
Measured: During repeated balance perturbations, up to 30 minutes
Biomechanical Stability Margin
Stability margin calculated from the relationship between center-of-pressure and center-of-mass displacement during recovery.
Measured: During repeated balance perturbations, up to 30 minutes
Reactive Step Threshold
Magnitude of support-surface perturbation that elicits a recovery step in approximately 50% of trials.
Measured: During initial reactive balance testing, up to 30 minutes
Gait Speed
Gait speed measured using a 10-meter walk test.
Measured: During clinical balance assessment at the single study visit
Clinical Balance Performance
Balance function assessed using the Mini-Balance Evaluation Systems Test (MiniBEST).
Measured: During clinical balance assessment at the single study visit
Cognitive Dual-Task Balance Performance
Balance performance evaluated during dual-task Timed Up and Go and beam-walking assessments.
Measured: During clinical balance assessment at the single study visit
Beam Walking Performance
Distance successfully traversed on a narrow beam under single-task and dual-task conditions.
Measured: During clinical balance assessment at the single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-site, single-session experimental study comparing cerebello-cortical connectivity and reactive balance adaptation in younger and older healthy adults. All participants will complete clinical balance assessments, transcranial magnetic stimulation (TMS), electroencephalography (EEG), electromyography (EMG), and a reactive balance task. Cerebello-cortical connectivity will be assessed before and after the reactive balance session to examine neurophysiological changes associated with balance adaptation and aging.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Palmer, PT, DPT, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901322
- Sponsor's protocol ID
- STUDY00026491
- Other IDs
- R21AG101558
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebello-cortical Connectivity as an Adaptive Mechanism for Balance Control With Aging
- ClinicalTrials.gov ID
- NCT07901322
- Acronym / sponsor ID
- STUDY00026491
- Conditions
- Aging, Postural Balance, Motor Adaptation
- Keywords
- Cerebello-cortical connectivity, Cerebellar brain inhibition, Electroencephalography, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 28 Oct 2026 (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.
This study will investigate how communication between the cerebellum and cerebral cortex contributes to balance control and adaptation in younger and older adults.
The study will enroll healthy younger adults ages 21-35 years and older adults ages 65-95 years. Participants will complete a single testing session that includes clinical balance assessments, transcranial magnetic stimulation (TMS), electroencephalography (EEG), electromyography (EMG), and reactive balance testing using an instrumented treadmill.
Cerebello-cortical connectivity will be measured before and after reactive balance testing using cerebellar brain inhibition (CBI) and the cerebellar TMS-evoked potential P80. The study will examine how these measures relate to cortical activity, balance recovery, and adaptation across repeated perturbations, and whether these relationships differ between younger and older adults.
Detailed description
Age-related changes in brain structure and function can contribute to declines in balance and mobility. The cerebellum may play an important role in maintaining balance and supporting motor adaptation during aging, but the neurophysiological mechanisms underlying cerebello-cortical connectivity and reactive balance control remain incompletely understood.
This single-site, single-session basic experimental study will investigate cerebello-cortical connectivity and its relationship to reactive balance control in younger and older adults. The study will recruit younger adults ages 21-35 years and older adults ages 65-95 years, with a target of 24 participants with usable primary data in each age group and an allowance for additional enrollment.
Participants will complete one laboratory visit lasting approximately three hours. The session will include screening, clinical balance and mobility assessments, instrumentation for EEG and EMG recording, pre-balance cerebellar TMS assessment, reactive balance testing, and post-balance cerebellar TMS assessment.
Cerebello-cortical connectivity will be assessed using dual-site paired-pulse TMS to measure cerebellar brain inhibition (CBI) of the primary motor cortex and cerebellar TMS-EEG to measure the P80 potential over the prefrontal cortex. These measures will be collected before and after the reactive balance session.
Reactive balance testing will be performed on an instrumented treadmill that delivers support-surface translations. Initial perturbations will determine each participant's reactive step threshold. Participants will then complete repeated perturbations to assess cortical responses, biomechanical stability, and balance adaptation. An overhead safety harness and trained research staff will provide support throughout testing.
Secondary assessments will include cortical coherence, the perturbation-evoked N1 response, biomechanical stability margin, gait speed, clinical balance performance, and cognitive dual-task balance. The study will examine whether cerebello-cortical connectivity mediates relationships between cortical activity and balance performance and whether changes in connectivity following balance adaptation differ by age group.
TMS is used solely as a non-invasive research measurement method and is not administered as a therapeutic intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-site, single-session experimental study comparing cerebello-cortical connectivity and reactive balance adaptation in younger and older healthy adults. All participants will complete clinical balance assessments, transcranial magnetic stimulation (TMS), electroencephalography (EEG), electromyography (EMG), and a reactive balance task. Cerebello-cortical connectivity will be assessed before and after the reactive balance session to examine neurophysiological changes associated with balance adaptation and aging.
| Arm | Type | Receives |
|---|---|---|
| Reactive Balance and Cerebello-Cortical Connectivity Assessment | Experimental | Device: Transcranial Magnetic Stimulation Assessment, Behavioral: Reactive Balance Adaptation TaskAll participants will undergo clinical balance assessments followed by transcranial magnetic stimulation (TMS) and TMS-EEG measurements before and after a single session of reactive balance testing. Reactive balance testing will involve support-surface perturbations delivered using an instrumented treadmill. Younger and older adults will undergo the same procedures, allowing comparison of cerebello-cortical connectivity and balance adaptation between age groups. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 21-35 years (younger adult group) or 65-95 years (older adult group).
- Willing and able to participate in and comply with all study procedures.
- Able to provide informed consent and communicate with study researchers.
- English-speaking.
- No major orthopedic disability.
Key exclusion criteria (12 listed)
- History of seizure, epilepsy, or convulsion in the participant or an immediate family member.
- Current use of antiepileptic medications.
- Metal or electrical implant in the head, neck, or chest, other than dental work.
- Any other contraindication identified on the TMS safety screening form.
- Pregnancy.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation AssessmentAlso: Magstim BiStim²Single-pulse and paired-pulse transcranial magnetic stimulation will be delivered using a Magstim BiStim² stimulator and compatible coils to assess cerebello-cortical excitability. Dual-site TMS will be used to assess cerebellar brain inhibition, and cerebellar TMS combined with EEG will be used to assess the P80 TMS-evoked potential. Measurements will be collected before and after reactive balance testing. TMS is used as a research measurement procedure, not as a therapeutic intervention. | Device | Reactive Balance and Cerebello-Cortical Connectivity Assessment |
| Reactive Balance Adaptation TaskAlso: Support-Surface Perturbation TestingParticipants will complete a single session of reactive balance testing on an instrumented treadmill. Support-surface translations of varying magnitude will first be delivered to determine the reactive step threshold, followed by repeated perturbations at a fixed magnitude to evaluate balance recovery and adaptation. Participants will wear an overhead safety harness, and trained research personnel will supervise all testing. | Behavioural | Reactive Balance and Cerebello-Cortical Connectivity Assessment |
Primary outcome
Change in Cerebellar Brain Inhibition (CBI) Ratio
Time frame: Before and after the reactive balance session, during a single study visit (up to 3 hours).
Cerebellar brain inhibition will be assessed using dual-site, paired-pulse transcranial magnetic stimulation and EMG recordings from the right tibialis anterior muscle. The CBI ratio will be calculated as the mean conditioned peak-to-peak motor-evoked potential amplitude divided by the mean single-pulse motor-evoked potential amplitude for each interstimulus interval. Lower ratios indicate stronger cerebellar inhibition.
Change in Cerebellar TMS-Evoked Potential P80 Amplitude
Time frame: Before and after the reactive balance session, during a single study visit (up to 3 hours).
The cerebellar TMS-evoked potential P80 will be measured using cerebellar TMS combined with EEG. P80 amplitude will be quantified as the peak EEG potential recorded over the contralateral dorsolateral prefrontal cortex within the 50-90 millisecond interval following TMS. Pre- and post-balance measurements will be compared.
8 secondary outcomes
Cortical Coherence During Reactive Balance Recovery
Time frame: During the reactive balance testing session, up to 30 minutes
Cortical N1 Response and Adaptation
Time frame: During repeated balance perturbations, up to 30 minutes
Biomechanical Stability Margin
Time frame: During repeated balance perturbations, up to 30 minutes
Reactive Step Threshold
Time frame: During initial reactive balance testing, up to 30 minutes
Gait Speed
Time frame: During clinical balance assessment at the single study visit
Clinical Balance Performance
Time frame: During clinical balance assessment at the single study visit
Cognitive Dual-Task Balance Performance
Time frame: During clinical balance assessment at the single study visit
Beam Walking Performance
Time frame: During clinical balance assessment at the single study visit
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 28 Oct 2026.
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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.
Jacqueline Palmer, PT, DPT, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation Assessment and Reactive Balance Adaptation Task in people with Aging and Postural Balance, run by University of Minnesota 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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Oct 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. 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?
Contact Jacqueline Palmer, PT, DPT, PhD (612-626-4364, brainsinmotion@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebellar Brain Inhibition (CBI) Ratio (time frame: Before and after the reactive balance session, during a single study visit (up to 3 hours).). The study lists 2 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 28 Oct 2026.