AgingEarly Phase 1NCT06779188
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
A Early Phase 1 study testing Transcranial Magnetic Stimulation in people with Aging and Balance Deficits, run by Weinberg Medical Physics LLC at 1 site in United States.
Trial summary
The goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems. The technique to manipulate the brain using magnets is known as transcranial magnetic stimulation or TMS. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Balance Deficits
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2025to 31 May 2027
- Phase
- Early Phase 1
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Able to provide informed consent b) All ethnic groups c) >65 years of age d) ≥2 non-injury falls or ≥1 injury fall in the past year [17]-[21] e) Absence of dementia/uncontrolled psychiatric disorder h) Able to walk and stand for 5 min continuously independently without assistance (i.e., cane, walker, ankle foot orthotics, electric scooter).
- Willingness to undergo MRI, participate in the 4-weeks intervention AND in the laboratory studies before, immediately-after, and 3-month after the intervention.
Who cannot join
- Inability to provide informed consent.
- Non-English speaking.
- Have contraindications to TMS based on TMS Adult Safety Screen (e.g., pregnancy, metal in the brain/skull, neurostimulator, pacemaker, infusion device, medication to treat mental illness)
- Unintentional weight loss of ≥10 pounds over the past year.
- Severe uncontrolled hypertension, or uncontrolled diabetes.
- Poor cognitive status (Montreal Cognitive Assessment (MoCA) score ≥ 26)
Show all 21Show fewer
- Untreated depression or Geriatric Depression Scale score on 15 item scale >7
- History of limb amputation (upper or lower extremity)
- Planned surgery in the next 3 months.
- History of chemotherapy or planned chemotherapy in the next 6 months or active malignancy.
- Severe osteoporosis, defined by diagnosis of osteoporosis with fracture.
- Pregnant or have a chance of being pregnant.
- Chronic inflammatory condition, autoimmune disease or infectious processes such as active tuberculosis, Human Immunodeficiency Virus, Rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C.
- Illicit drug use
- Use of medications that may increase the risk of falling:
- Sedatives
- Hypnotics
- Anti-cholinergic
- Benzodiazepines
- Anti-depressants
- Intracranial bleeds visible on their most recent CT or MRI scans.
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, 1 recruiting
- Recruiting
The Center for Neuromotor and Biomechanics Research at the University of Houston
Houston, Texas, 77204
Pranav J Parikh, MBBS, PhD, 713-743-0503, pjparikh2@uh.edu
Pranav J Parikh, MBBS, PhD
About this study
Official title: Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity
The goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems. The technique to manipulate the brain using magnets is known as transcranial magnetic stimulation or TMS.
The main questions this study aims to answer are:
Read more
- How does TMS change communication between brain areas?
- Does TMS improve balance ability in older adults with balance problems? Researchers will compare the TMS group to a placebo group to see if manipulating the brain using magnets works to treat balance impairment.
Participants will:
- Receive TMS or placebo stimulation for 4 weeks.
- Visit the laboratory for checkups and tests 3 times.
Read the detailed description
Falls and fall-related injuries are a growing public health concern, particularly in regions of the world in which high proportions of the population are elderly. When these older adults are affected with neurological conditions such as stroke, neuropathies, Parkinson's disease, Alzheimer's disease, the risk for falls increases more than 3-fold. Falls and the resulting fear of falls can mark the beginning of a decline in function, participation in social activities, and independence, thus negatively affecting the quality of life.
The aim of this project is to use electroencephalography-guided TMS to improve balance in elderly patients with a history of falls, through repair of (or compensation for) abnormal brain connectivity. The entire study will be done at the University of Houston in Dr. Parikh's laboratory (PI) in the Center for Neuromotor and Biomechanics laboratory (CNBR).
The investigators will enroll 30 older adults with balance problems. Participants will be randomly and equally assigned to a treatment group (A) and a placebo (sham) group (B). Each participant will undergo a MRI scan at the MRI center. Participants will not be responsible for MRI-related costs. This will be followed by baseline assessments of brain connectivity using electroencephalography (EEG) and balance assessment. Participants in both groups will receive a 4-week long intervention (once daily, 5 days a week). Immediately following the intervention period, EEG and balance assessments will be repeated. A 3-month follow-up will be conducted.
- Conditions
- Aging, Balance Deficits
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- TMS, Balance, Brain stimulation, Elderly, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
TMS (in the form of theta burst stimulations) will be delivered over Supplementary Motor Area while the subject is seated in the Treatment group. TMS is capable to induce neuroplastic facilitatory changes in the brain that last beyond the duration of stimulation. TMS will be delivered once daily, 5 days per week, for 4 weeks.
Transcranial Magnetic Stimulation ShamDevice
Sham TMS will be delivered in the sham group using a sham coil once daily, 5 days per week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants in this group will receive transcranial magnetic stimulation (TMS) once daily, 5 days a week. TMS will be in the form of accelerated repetitive TMS. TMS is a safe technique when handled by experts. Receives: Device: Transcranial Magnetic Stimulation |
| Sham group | Sham comparator | Participants in this group will receive sham (placebo) TMS once daily, 5 days a week. Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography functional connectivity
Electroencephalography (EEG) will be used to measure the brain activity. The brain circuitry responsible for balance will be evaluated with EEG projected onto individual anatomical MRI. Directed functional connectivity between two regions of activation will be computed. The higher the functional connectivity coefficient, the stronger the connectivity.
Measured: Before and immediately-after the intervention and at 3- month follow-up
miniBESTest
It provides a comprehensive assessment of anticipatory and reactive postural control, sensory orientation, and dynamic gait.
Measured: Before and immediately-after the intervention and at 3- month follow-up
Secondary outcomes (2)
Activities-Specific Balance Confidence scale (Aim 2)
It consists of 16 items describing different situations that might lead to a loss of balance. For each time, scoring is done from 0-100 (0 is no confidence and 100 is full confidence). The total score is calculated by adding up all the individual item scores and dividing by 16. The Activities-Specific Balance Confidence total score is known to predict falls in elderly subjects.
Measured: Before and immediately-after the intervention and at 3- month follow-up
Root mean square of foot center of pressure on the balance task
It is calculated from the ground reaction forces.
Measured: Before and immediately-after the intervention and at 3- month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start6 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion31 May 2027 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weinberg Medical Physics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Houston, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779188
- Sponsor's protocol ID
- STUDY00004556
- Other IDs
- R41AG085838
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity
- ClinicalTrials.gov ID
- NCT06779188
- Acronym / sponsor ID
- STUDY00004556
- Conditions
- Aging, Balance Deficits
- Keywords
- TMS, Balance, Brain stimulation, Elderly, Treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Weinberg Medical Physics LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Houston, National Institute on Aging (NIA)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Jan 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 goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems. The technique to manipulate the brain using magnets is known as transcranial magnetic stimulation or TMS.
The main questions this study aims to answer are:
- How does TMS change communication between brain areas?
- Does TMS improve balance ability in older adults with balance problems? Researchers will compare the TMS group to a placebo group to see if manipulating the brain using magnets works to treat balance impairment.
Participants will:
- Receive TMS or placebo stimulation for 4 weeks.
- Visit the laboratory for checkups and tests 3 times.
Detailed description
Falls and fall-related injuries are a growing public health concern, particularly in regions of the world in which high proportions of the population are elderly. When these older adults are affected with neurological conditions such as stroke, neuropathies, Parkinson's disease, Alzheimer's disease, the risk for falls increases more than 3-fold. Falls and the resulting fear of falls can mark the beginning of a decline in function, participation in social activities, and independence, thus negatively affecting the quality of life.
The aim of this project is to use electroencephalography-guided TMS to improve balance in elderly patients with a history of falls, through repair of (or compensation for) abnormal brain connectivity. The entire study will be done at the University of Houston in Dr. Parikh's laboratory (PI) in the Center for Neuromotor and Biomechanics laboratory (CNBR).
The investigators will enroll 30 older adults with balance problems. Participants will be randomly and equally assigned to a treatment group (A) and a placebo (sham) group (B). Each participant will undergo a MRI scan at the MRI center. Participants will not be responsible for MRI-related costs. This will be followed by baseline assessments of brain connectivity using electroencephalography (EEG) and balance assessment. Participants in both groups will receive a 4-week long intervention (once daily, 5 days a week). Immediately following the intervention period, EEG and balance assessments will be repeated. A 3-month follow-up will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Transcranial Magnetic StimulationParticipants in this group will receive transcranial magnetic stimulation (TMS) once daily, 5 days a week. TMS will be in the form of accelerated repetitive TMS. TMS is a safe technique when handled by experts. |
| Sham group | Sham comparator | Device: Transcranial Magnetic Stimulation ShamParticipants in this group will receive sham (placebo) TMS once daily, 5 days a week. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to provide informed consent b) All ethnic groups c) >65 years of age d) ≥2 non-injury falls or ≥1 injury fall in the past year [17]-[21] e) Absence of dementia/uncontrolled psychiatric disorder h) Able to walk and stand for 5 min continuously independently without assistance (i.e., cane, walker, ankle foot orthotics, electric scooter).
- Willingness to undergo MRI, participate in the 4-weeks intervention AND in the laboratory studies before, immediately-after, and 3-month after the intervention.
Key exclusion criteria (21 listed)
- Inability to provide informed consent.
- Non-English speaking.
- Have contraindications to TMS based on TMS Adult Safety Screen (e.g., pregnancy, metal in the brain/skull, neurostimulator, pacemaker, infusion device, medication to treat mental illness)
- Unintentional weight loss of ≥10 pounds over the past year.
- Severe uncontrolled hypertension, or uncontrolled diabetes.
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 StimulationTMS (in the form of theta burst stimulations) will be delivered over Supplementary Motor Area while the subject is seated in the Treatment group. TMS is capable to induce neuroplastic facilitatory changes in the brain that last beyond the duration of stimulation. TMS will be delivered once daily, 5 days per week, for 4 weeks. | Device | Treatment group |
| Transcranial Magnetic Stimulation ShamSham TMS will be delivered in the sham group using a sham coil once daily, 5 days per week, for 4 weeks. | Device | Sham group |
Primary outcome
Electroencephalography functional connectivity
Time frame: Before and immediately-after the intervention and at 3- month follow-up
Electroencephalography (EEG) will be used to measure the brain activity. The brain circuitry responsible for balance will be evaluated with EEG projected onto individual anatomical MRI. Directed functional connectivity between two regions of activation will be computed. The higher the functional connectivity coefficient, the stronger the connectivity.
miniBESTest
Time frame: Before and immediately-after the intervention and at 3- month follow-up
It provides a comprehensive assessment of anticipatory and reactive postural control, sensory orientation, and dynamic gait.
2 secondary outcomes
Activities-Specific Balance Confidence scale (Aim 2)
Time frame: Before and immediately-after the intervention and at 3- month follow-up
Root mean square of foot center of pressure on the balance task
Time frame: Before and immediately-after the intervention and at 3- month follow-up
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 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transcranial Magnetic Stimulation in people with Aging and Balance Deficits, run by Weinberg Medical Physics LLC 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 2 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 28 Aug 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Pranav J Parikh, MBBS, PhD (713-743-0503, pjparikh2@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography functional connectivity (time frame: Before and immediately-after the intervention and at 3- month follow-up). 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 Aug 2026.