Recruiting
Early Phase 1

TMS

Sponsor:

Weinberg Medical Physics LLC

Code:

NCT06779188

Conditions

Aging

Balance Deficits

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation Sham

Study Details

Brief 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.

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.

Conditions

Aging

Balance Deficits

Study ID

NCT06779188

Start date

May 6, 2025

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

a) 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).

i) Willingness to undergo MRI, participate in the 4-weeks intervention AND in the laboratory studies before, immediately-after, and 3-month after the intervention.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Non-English speaking.
3. 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)
4. Unintentional weight loss of ≥10 pounds over the past year.
5. Severe uncontrolled hypertension, or uncontrolled diabetes.
6. Poor cognitive status (Montreal Cognitive Assessment (MoCA) score ≥ 26)
7. Untreated depression or Geriatric Depression Scale score on 15 item scale >7
8. History of limb amputation (upper or lower extremity)
9. Planned surgery in the next 3 months.
10. History of chemotherapy or planned chemotherapy in the next 6 months or active malignancy.
11. Severe osteoporosis, defined by diagnosis of osteoporosis with fracture.
12. Pregnant or have a chance of being pregnant.
13. 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.
14. Illicit drug use
15. Use of medications that may increase the risk of falling:

  • Sedatives
  • Hypnotics
  • Anti-cholinergic
  • Benzodiazepines
  • Anti-depressants
16. Intracranial bleeds visible on their most recent CT or MRI scans.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

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.

sham comparator: Sham group

Participants in this group will receive sham (placebo) TMS once daily, 5 days a week.

Interventions

Transcranial Magnetic Stimulation

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 Sham

Sham TMS will be delivered in the sham group using a sham coil once daily, 5 days per week, for 4 weeks.

Primary outcome measure

  • Electroencephalography functional connectivity [ Time Frame: Before and immediately-after the intervention and at 3- month follow-up ]
  • miniBESTest [ Time Frame: Before and immediately-after the intervention and at 3- month follow-up ]

Central Contacts and Locations

Central contacts

Pranav J Parikh, MBBS, PhD

713-743-0503pjparikh2@uh.edu

Locations

The Center for Neuromotor and Biomechanics Research at the University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Pranav J Parikh, MBBS, PhD

713-743-0503pjparikh2@uh.edu

Principal Investigator:

Pranav J Parikh, MBBS, PhD

More Information

Sponsor

Weinberg Medical Physics LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • TMS
  • Balance
  • Brain stimulation
  • Elderly
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weinberg Medical Physics LLC on 2026-08-28.