Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
Is Transcranial Direct Current Stimulation (tDCS) a promising treatment for Carpal Tunnel Syndrome?The information provided does not directly address Transcranial Direct Current Stimulation (tDCS) as a treatment for Carpal Tunnel Syndrome. The articles focus on other treatments like acupuncture, nerve stimulation, and ultrasound, but do not mention tDCS. Therefore, we cannot conclude if tDCS is promising based on this information.1781012
What safety data exists for noninvasive brain stimulation treatments like tDCS and TUS?Transcranial Direct Current Stimulation (tDCS) is generally considered safe and well-tolerated, with no severe complications reported in adults or children at intensities of 4 mA or less for up to 60 minutes per day. Safety data from over 33,200 sessions and 1000 subjects show no serious adverse effects or irreversible injuries. Adverse events are typically low and transient. Animal studies suggest the electrical dose used in tDCS is significantly below levels that could cause permanent brain tissue changes. However, skin irritation and occasional injuries have been noted, and safety profiles prevent high current delivery when skin resistance is high. There is less information available on Transcranial Ultrasound (TUS) specifically, but the focus here is on tDCS.3461113
What data supports the idea that Noninvasive Brain Stimulation for Carpal Tunnel Syndrome is an effective treatment?The available research shows that noninvasive brain stimulation, specifically transcranial direct current stimulation (tDCS), has been effective in improving hand motor skills in patients with chronic stroke. Although this research focuses on stroke patients, it suggests that tDCS can help improve hand function, which might be beneficial for conditions like Carpal Tunnel Syndrome. However, there is no direct evidence from the provided research specifically supporting its effectiveness for Carpal Tunnel Syndrome.2591415
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have used carbamazepine in the past 6 months.
Eligibility Criteria
This trial is for adults aged 18-80 with Carpal Tunnel Syndrome causing chronic pain despite previous treatments. Participants must have had pain for at least 6 months, feel it on most days, and rate it at least a 3 out of 10. They can't join if they're pregnant, have used certain medications recently, suffer from major depression or neurological issues like stroke or epilepsy, have metal implants in the brain, or a history of substance abuse.Inclusion Criteria
I am between 18 and 80 years old.
I have chronic wrist pain from CTS, spreading beyond the usual areas, for over 6 months.
My chronic pain persists despite first-line treatments.
Exclusion Criteria
I do not have any metal implants in my head.
I have severe depression, as shown by my PHQ-9 score.
I have had brain surgery.
Treatment Details
The study tests whether transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) can reduce pain in Carpal Tunnel Syndrome patients better than sham (fake) stimulation. The hypothesis is that active stimulation will lower pain levels more effectively.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS + Active TUSExperimental Treatment2 Interventions
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Group II: Sham tDCS + Sham TUSPlacebo Group2 Interventions
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Transcranial Direct Current Stimulation for:
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
🇪🇺 Approved in European Union as Transcranial Direct Current Stimulation for:
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
🇨🇦 Approved in Canada as Transcranial Direct Current Stimulation for:
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
🇦🇺 Approved in Australia as Transcranial Direct Current Stimulation for:
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
Spaulding Rehabilitation Network Research InstituteCharlestown, MA
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Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
Highland Instruments, Inc.Industry Sponsor
References
Carpal tunnel syndrome: clinical outcome after low-level laser acupuncture, microamps transcutaneous electrical nerve stimulation, and other alternative therapies--an open protocol study. [2004]Outcome for carpal tunnel syndrome (CTS) patients (who previously failed standard medical/surgical treatments) treated primarily with a painless, noninvasive technique utilizing red-beam, low-level laser acupuncture and microamps transcutaneous electrical nerve stimulation (TENS) on the affected hand; secondarily, with other alternative therapies.
Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. [2022]To systematically review the methodology in particular treatment options and outcomes and the effect of multiple sessions of transcranial direct current stimulation (tDCS) with rehabilitation programmes for upper extremity recovery post stroke.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
Effects of anodal tDCS and occupational therapy on fine motor skill deficits in patients with chronic stroke. [2018]A growing body of evidence supports the effectiveness of using transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment resulting from stroke.
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated. However, few studies have examined the safety, tolerability, or blinding of High Definition (HD-) tDCS, especially in older adults and at stimulation intensities of 2 milliamps (mA) or greater.
Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome. [2022]Carpal tunnel syndrome (CTS) is a compressive neuropathic disorder at the level of the wrist. Acupuncture and other methods that stimulate acupuncture points, such as electroacupuncture, auricular acupuncture, laser acupuncture, moxibustion, and acupressure, are used in treating CTS. Acupuncture has been recommended as a potentially useful treatment for CTS, but its effectiveness remains uncertain. We used Cochrane methodology to assess the evidence from randomised and quasi-randomised trials of acupuncture for symptoms in people with CTS.
Ultrasound therapy adds no benefit to splinting in carpal tunnel syndrome. [2020]Therapeutic ultrasound has been suggested as a treatment for carpal tunnel syndrome (CTS), but existing trial evidence is of poor quality and inconclusive.
Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. [2020]Transcranial direct current stimulation (tDCS) is a treatment used in the rehabilitation of stroke patients aiming to improve functionality of the plegic upper extremity. Currently, tDCS is not routinely used in post stroke rehabilitation. The aim of this study was to establish the effects of bihemspheric tDCS combined with physical therapy (PT) and occupational therapy (OT) on upper extremity motor function.
The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. [2021]Carpal tunnel syndrome (CTS) is a disorder with a prevalence of about 5.8% for females and 0.6% for males. This study aims to determine whether intramuscular stimulation (IMS) to the pronator teres muscle subsequently reduces the severity of clinical parameters and the diameter of the median nerve.
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]Transcranial direct current stimulation (tDCS) is reported to induce irritating skin sensations and occasional skin injuries, which limits the applied tDCS dose. Additionally, tDCS hardware safety profile prevents high current delivery when skin resistance is high.
The effectiveness of the median nerve neurodynamic mobilisation techniques in women with mild or moderate bilateral carpal tunnel syndrome: A single-blind clinical randomised trial. [2022]Carpal tunnel syndrome (CTS) is the most prevalent upper limb compression neuropathy. Surgical or nonsurgical treatment is recommended. Both mild and moderate CTS can be managed conservatively. Neurodynamic mobilisation techniques (NMTs) of the median nerve have not been widely studied, and conflicting findings exist.
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]Transcranial direct current stimulation (tDCS) has considerable potential as a useful method in the field of neurorehabilitation. However, the safety of tDCS for the human is primarily based on theoretical evidence related to electricity, and the safety information of applying tDCS to the human is only available from researcher's reporting. Based on tDCS studies with human and animal subjects and simulation-based studies of the safety of current stimulation in the past 20 years, this review investigated the safety of tDCS application to the human body. No severe complications have been reported in either adults or children for tDCS at an intensity of 4 mA or less, within a period of 60 minutes per day, using commonly applied 25 or 35 cm2 electrodes. According to animal studies, the amount of electricity used for tDCS is less than 5% of the amount that permanently changes brain tissue, thereby ensuring safety to a certain extent. In order to increase the efficacy of tDCS for neurorehabilitation and to minimize even trivial complications in the human screening of exclusion criteria should be conducted with detailed observations of complications.
Comparative efficacy of different noninvasive brain stimulation therapies for recovery of global cognitive function, attention, memory, and executive function after stroke: a network meta-analysis of randomized controlled trials. [2023]Which noninvasive brain stimulation (NIBS) treatment - transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS) - is more beneficial for stroke patients' cognitive rehabilitation is still up for debate.
Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]Transcranial direct current stimulation (tDCS) has been shown to benefit patients with brain lesions or traumatic brain injury (TBI). These patients usually have skull defects with different sizes and electrical conductivities. There is very little data in the literature that show how to optimally stimulate these patients with the presence of skull defects.