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Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor
Stuart H Isaacson1, Elizabeth Peckham2, Winona Tse3
1Parkinson's Disease and Movement Disorders of Boca Raton, Boca Raton, FL, US.
Tremor and Other Hyperkinetic Movements (New York, N.Y.)
|September 1, 2020
Summary
This study shows that non-invasive neuromodulation therapy, used daily at home for three months, safely and effectively reduces essential tremor (ET) and improves patients' quality of life.
Area of Science:
- Neurology
- Biomedical Engineering
Background:
- Previous single-session trials demonstrated the efficacy of non-invasive neuromodulation for tremor reduction.
- This study evaluated the therapy's effectiveness and safety with repeated home use over three months.
Purpose of the Study:
- To assess the long-term efficacy and safety of individualized non-invasive neuromodulation therapy for essential tremor (ET).
- To evaluate tremor reduction and quality of life improvements in ET patients using the therapy at home.
Main Methods:
- A prospective, open-label, single-arm study with 263 essential tremor patients.
- Patients used the non-invasive neuromodulation therapy twice daily for three months.
- Primary endpoints included clinician-rated (TETRAS) and patient-rated (BF-ADL) tremor assessments.
Main Results:
- Co-primary endpoints were met, with significant improvements in TETRAS (62%) and BF-ADL (68%) scores.
- 68% of patients showed clinician-reported improvement, 60% reported patient-assessed improvement, and quality of life (QUEST) improved.
- Accelerometer data showed 92% of patients improved tremor power, with 54% experiencing ≥50% reduction. Adverse events were mild and infrequent.
Conclusions:
- Individualized non-invasive neuromodulation therapy is safe and effective for home use in essential tremor patients.
- Repeated, long-term application of this therapy significantly reduces hand tremor and enhances quality of life.
