Electrical Stimulation for Tremor

Overseen By Grace Hoo, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Neurological diseases, Parkinsonism, Epilepsy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of electrical stimulation can aid movement and control in the arms. It targets individuals with essential tremor (shaking hands and arms) and includes healthy participants for comparison. The trial tests two methods: one using pads on the skin and another using small leads under the skin, both designed to improve hand and arm movements. Individuals with essential tremor, who experience noticeable arm shaking, and those without tremor or neurological issues may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for essential tremor.

Will I have to stop taking my current medications?

The trial requires that ET patients have stable medication doses for at least 30 days before joining and throughout the study, so you should not stop taking your current medications.

What prior data suggests that this electrical stimulation technique is safe for tremor treatment?

In a previous study, researchers found that non-invasive electrical stimulation on nerves is generally safe for managing tremors. For treatments involving needles (percutaneous asES), a study with patients who have tremors showed that stimulating certain nerves in the arm significantly reduced tremors and was well-tolerated. Another study on nerve stimulation found it effective and reported no serious side effects.

For treatments using pads on the skin (transcutaneous asES), multiple studies have shown it to be safe and effective in reducing tremors. Real-world evidence supports its safety, confirming that many patients with essential tremor (ET) experienced tremor control without serious adverse effects.

Both treatments have demonstrated promising safety records, with reports of effective tremor management and minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electrical stimulation for tremor because it offers a non-invasive alternative to traditional treatments like medications or surgery. This approach uses electrical impulses to specifically target and stimulate nerves and muscles in the wrist, potentially reducing tremors more precisely and with fewer side effects. Unlike standard drug therapies that can have systemic effects, these treatments focus directly on the tremor's source, offering a more localized and potentially safer option. With both percutaneous and transcutaneous methods being explored, there's potential for flexibility in treatment application, catering to different patient needs and preferences.

What evidence suggests that this trial's treatments could be effective for essential tremor?

This trial will compare two methods of electrical stimulation for tremor reduction. Studies have shown that electrical stimulation can help reduce tremors. Participants in one arm of this trial will receive percutaneous asES, where some patients have experienced significant tremor reduction, with improvements of over 75% in certain cases. Another arm will involve transcutaneous asES, which has also proven effective, providing noticeable tremor reduction for at least an hour after treatment in some patients. Both methods stimulate nerves to help control tremors, often focusing on muscles or nerves in the arms. Multiple studies support this approach, showing promise for people with essential tremor. ^{4 6 7 8 9}

Who Is on the Research Team?

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with essential tremor (ET) and healthy individuals without tremors. ET patients must have a moderate-severe wrist tremor, no skull lesions or history of significant head trauma, stable medication doses, and normal hearing/vision. Healthy participants need normal neurological function and cannot be pregnant or have a history of substance abuse.

Inclusion Criteria

I have been diagnosed with Essential Tremor by a doctor.

I do not have tremors.

I have a moderate to severe hand tremor that worsens when I hold my arm out.

Exclusion Criteria

I have had brain surgery before.

Healthy Participants: Tremors (as determined by study team)

Healthy Participants: Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous or percutaneous afferent-specific electrical stimulation to study its effects on proprioception and fine motor control

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for acute, short-term, and long-term effects of the stimulation on proprioception and fine motor control

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Sensory Electrical Stimulation

Trial Overview

The study tests the effects of sensory electrical stimulation on proprioception (sense of body position) and motor control in people with ET and healthy controls. It involves non-invasive electrical stimulation strategies, muscle activity recording (HD-EMG), arm movement tracking, and clinical assessments.

How Is the Trial Designed?

Group I: Transcutaneous asES Experimental Treatment 2 Interventions

Participants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist

Group II: Percutaneous asES Experimental Treatment 2 Interventions

Participants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

In a study involving 18 patients with essential tremor, sensory electrical stimulation applied to multiple upper limb muscles significantly reduced tremor intensity during stimulation, with a notable 90% decrease in peak power of the index finger.

The effects of the sensory stimulation persisted for at least 5 minutes after the stimulation ended, suggesting that this method could be a promising clinical treatment for managing essential tremor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory electrical stimulation for suppression of postural tremor in patients with essential tremor. Heo, JH., Kim, JW., Kwon, Y., et al.[2015]

A closed-loop system using transcutaneous electrical nerve stimulation (TENS) effectively detects and suppresses tremors in patients with Parkinson's disease, as demonstrated in preliminary tests with 2 PD subjects.

The system works by stimulating sensory fibers beneath the skin, which inhibits propriospinal neurons and significantly reduces tremor activity, showing promise for improving daily functioning in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a closed-loop system for tremor suppression in patients with Parkinson's disease. Xu, FL., Hao, MZ., Xu, SQ., et al.[2020]

A systematic review of 15 studies involving 627 participants found that somatosensory stimulation, including sensory electrical stimulation, did not significantly improve upper limb motor function compared to placebo or usual care after stroke.

The evidence regarding the efficacy of somatosensory stimulation is low to moderate quality, indicating that it may not be an effective intervention for enhancing motor recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatosensory stimulation to improve hand and upper limb function after stroke-a systematic review with meta-analyses. Grant, VM., Gibson, A., Shields, N.[2018]

In a study involving 12 chronic subcortical stroke patients, electrical somatosensory stimulation of the median nerve in the affected hand significantly improved motor performance, including increased frequency of finger tapping and better reach-to-grasp movements.

The stimulation did not affect the motor performance of the unaffected hand, indicating a targeted benefit for the affected side, suggesting potential for rehabilitation strategies in improving hand function post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical somatosensory stimulation improves movement kinematics of the affected hand following stroke. Koesler, IB., Dafotakis, M., Ameli, M., et al.[2017]

Non-invasive electrical stimulation of peripheral nerves has emerged as a safe and effective treatment for reducing pathological tremor in patients with essential tremor and Parkinson's disease, providing an alternative to traditional medications and surgical options.

The review highlights that one specific peripheral electrical stimulation therapy has been cleared for prescription and home use, indicating its clinical translatability and potential to improve tremor management in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive electrical stimulation of peripheral nerves for the management of tremor. Pascual-Valdunciel, A., Rajagopal, A., Pons, JL., et al.[2023]

Electrical stimulation in the target area (VL) for treating parkinsonian tremor and spasmodic torticollis can enhance muscle tone, suggesting that this area plays a crucial role in muscle control.

The study indicates that properly locating lesions and interrupting muscle afferents are key factors for achieving effective treatment outcomes in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatosensory evoked potentials in the ventrolateral thalamus. Birk, P., Riescher, H., Struppler, A., et al.[2019]

The Kinetra dual channel stimulator was found to be safe and effective for patients with severe Parkinson's disease and essential tremor, with no device failures or unexpected adverse events reported during the study of 129 patients.

Patients experienced significant improvements in motor scores and daily activities, similar to those achieved with traditional single channel stimulators, suggesting that Kinetra may offer enhanced benefits for managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual channel deep brain stimulation system (Kinetra) for Parkinson's disease and essential tremor: a prospective multicentre open label clinical study. Vesper, J., Chabardes, S., Fraix, V., et al.[2019]

Functional electrical stimulation (FES) significantly reduced upper limb physiological tremor in healthy subjects, with a decrease in tremor power spectral density by 62.18% and root mean square by 57.16%.

However, the presence of augmented visual feedback negated the positive effects of FES on tremor, indicating that visual cues can interfere with the benefits of electrical stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented visual feedback counteracts the effects of surface muscular functional electrical stimulation on physiological tremor. Grimaldi, G., Fernandez, A., Manto, M.[2021]

A home-based intervention using sensory amplitude electrical stimulation (SES) via sock electrodes combined with standing and mobility activities showed a significant improvement in gait speed among 13 adults with chronic stroke over 6 weeks.

While other functional outcomes did not show significant changes, medium effect sizes were observed for the Stroke Rehabilitation Assessment of Movement-LE and Monofilament testing, suggesting potential benefits in sensory and movement recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory Amplitude Electrical Stimulation via Sock Combined With Standing and Mobility Activities Improves Walking Speed in Individuals With Chronic Stroke: A Pilot Study. Lopez-Rosado, R., Kimalat, A., Bednarczyk, M., et al.[2020]

Intramuscular electrical stimulation using a selective and adaptive timely stimulation (SATS) approach resulted in an average 32% reduction in tremor during stimulation in nine patients with Essential Tremor, demonstrating its efficacy.

The SATS method not only provided immediate tremor relief but also led to prolonged tremor reduction lasting up to 24 hours after stimulation, suggesting it could be a promising alternative treatment for Essential Tremor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular Stimulation of Muscle Afferents Attains Prolonged Tremor Reduction in Essential Tremor Patients. Pascual-Valdunciel, A., Gonzalez-Sanchez, M., Muceli, S., et al.[2021]

A pilot study involving 4 participants with sensory loss post-stroke showed that repetitive electrical stimulation (tactile coactivation) significantly improved sensory discrimination and motor task performance after 6 weeks of treatment.

Improvements in sensory and motor functions were observed immediately after treatment and persisted for at least 4 weeks, suggesting that tactile coactivation could be a promising therapy for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive electrical stimulation to treat sensory loss in persons poststroke. Smith, PS., Dinse, HR., Kalisch, T., et al.[2016]

In a pilot study involving 11 individuals with chronic stroke, combining task-specific training with sensory amplitude electrical stimulation (SES) via glove electrodes led to significant improvements in arm sensation and function, as measured by various assessments including the Jebsen-Taylor Hand Function Test.

The benefits of this combined approach were maintained for at least three months after the intervention, particularly for individuals with better baseline motor capacity and those who had experienced a more recent stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving arm function in chronic stroke: a pilot study of sensory amplitude electrical stimulation via glove electrode during task-specific training. Sullivan, J., Girardi, M., Hensley, M., et al.[2022]

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