Trial reportNeuromodulation : journal of the International Neuromodulation Society2021
A Prospective, Multicenter Study to Assess the Safety and Efficacy of Translingual Neurostimulation Plus Physical Therapy for the Treatment of a Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury.
Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 26 citations in OpenAlex.
- A feasibility study on the use of cranial nerve non-invasive neuromodulation to improve affected arm function in people in the chronic stage of a stroke.BMC neurology · 2025Trial
- Article
- Inflammatory profiling for precision neurorehabilitation after traumatic brain injury and stroke: a narrative review.Frontiers in neurology · 2026Review
- Translingual neural stimulation induced changes in intra- and inter-network functional connectivity in mild-moderate traumatic brain injury patients.Frontiers in human neuroscience · 2025Article
- Trigeminal nerve stimulation: a current state-of-the-art review.Bioelectronic medicine · 2023Review
- Wearable Technologies Using Peripheral Neuromodulation to Enhance Mobility and Gait Function in Older Adults-A Narrative Review.The journals of gerontology. Series A, Biological sciences and medical sciences · 2023Review
- Real world evidence of improved attention and cognition during physical therapy paired with neuromodulation: a brain vital signs study.Frontiers in human neuroscience · 2023Article
- Translingual neural stimulation affects resting-state functional connectivity in mild-moderate traumatic brain injury.Journal of neuroimaging : official journal of the American Society of Neuroimaging · 2022Article
- Update on Non-Pharmacological Interventions for Treatment of Post-Traumatic Headache.Brain sciences · 2022Review
- The role of electrical stimulation for rehabilitation and regeneration after spinal cord injury.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2022Review
- Cranial Nerve Noninvasive Neuromodulation in Adults With Neurological Conditions: Protocol for a Scoping Review.JMIR research protocols · 2021Article
- Portable neuromodulation induces neuroplasticity to re-activate motor function recovery from brain injury: a high-density MEG case study.Journal of neuroengineering and rehabilitation · 2020Article
- Brain Vital Signs Detect Information Processing Differences When Neuromodulation Is Used During Cognitive Skills Training.Frontiers in human neuroscience · 2020Article
- The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.Frontiers in aging neuroscience · 2020Article
- Brain Vital Signs Detect Cognitive Improvements During Combined Physical Therapy and Neuromodulation in Rehabilitation From Severe Traumatic Brain Injury: A Case Report.Frontiers in human neuroscience · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 2 countries.
Funding
Abstract
objectivesTranslingual neurostimulation (TLNS) studies indicate improved outcomes in neurodegenerative disease or spinal cord injury patients. This study was designed to assess the safety and efficacy of TLNS plus targeted physical therapy (PT) in people with a chronic balance deficit after mild-to-moderate traumatic brain injury (mmTBI). MATERIALS AND
methodsThis international, multicenter, randomized study enrolled 122 participants with a chronic balance deficit who had undergone PT following an mmTBI and had plateaued in recovery. Randomized participants received PT plus either high-frequency pulse (HFP; n = 59) or low-frequency pulse (LFP; n = 63) TLNS. The primary efficacy and safety endpoints were the proportion of sensory organization test (SOT) responders (SOT composite score improvement of ≥15 points) and fall frequency after five weeks of treatment, respectively.
resultsThe proportion of SOT responders was significant in the HFP + PT (71.2%) and LFP + PT (63.5%) groups compared with baseline (p < 0.0005). For the pooled population, the SOT responder rate was 67.2% (p < 0.00005), and there were clinically and statistically significant improvements in SOT composite scores after two and five weeks (p < 0.0005). Both groups had reductions in falls and headache disability index scores. Mean dynamic gait index scores in both groups also significantly increased from baseline at weeks 2 and 5.
conclusionsSignificant improvements in balance and gait, in addition to headaches, sleep quality, and fall frequency, were observed with TLNS plus targeted PT; in participants who had a chronic balance deficit following an mmTBI and had plateaued on prior conventional physiotherapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.