Using magnets to improve balance in older adults with balance problems
Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity
This study tests if using magnets on the brain can help older adults with balance problems improve their balance and reduce the risk of falls.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Weinberg Medical Physics LLC Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06779188 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of transcranial magnetic stimulation (TMS) on brain connectivity and balance ability in older adults who have experienced balance issues. Participants will be randomly assigned to receive either TMS or a placebo stimulation over a four-week period, with assessments of brain connectivity and balance conducted before, immediately after, and three months post-intervention. The research seeks to determine if TMS can enhance communication between brain areas and improve balance, potentially reducing the risk of falls in this population.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who have experienced multiple falls in the past year but do not have dementia or uncontrolled psychiatric disorders.
Not a fit: Patients who are non-English speaking, have contraindications to TMS, or severe uncontrolled health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce fall-related injuries and improve the quality of life for older adults with balance problems.
How similar studies have performed: While the use of TMS for various neurological conditions has shown promise, this specific application for improving balance in older adults is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- The Center for Neuromotor and Biomechanics Research at the University of Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Pranav J Parikh, MBBS, PhD
- Email: pjparikh2@uh.edu
- Phone: 713-743-0503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.