TENS for Multiple Sclerosis Fatigue
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Boulder
Must be taking: Ampyra, Provigil
Must not be taking: Antidepressants, Anticholinergics, Stimulants, Sedatives
Disqualifiers: Diabetes, Hypertension, Seizure disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.
Will I have to stop taking my current medications?
The trial requires that participants are on stable doses of medications like Ampyra or Provigil, but you cannot participate if you are taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs, or medications for herpes or neurologic pain.
What data supports the effectiveness of the treatment TENS for reducing fatigue in multiple sclerosis?
Research shows that TENS can reduce pain and fatigue in people with fibromyalgia, suggesting it might also help with similar symptoms in multiple sclerosis. Additionally, TENS has been evaluated for treating sensory complaints in MS, indicating potential benefits for managing fatigue.
12345Is TENS safe for use in humans?
TENS (transcutaneous electrical nerve stimulation) is generally considered safe for humans, with minor side effects reported in some cases. In studies involving fibromyalgia, the number of people experiencing minor adverse effects from TENS was low, suggesting it is a safe option for managing pain and fatigue.
16789How does TENS treatment differ from other treatments for multiple sclerosis fatigue?
TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it is a non-drug therapy that uses electrical currents to relieve symptoms, unlike many treatments that rely on medications with potential side effects. It is applied externally and can be used at home, offering a convenient and side-effect-free option for managing fatigue in multiple sclerosis.
49101112Eligibility Criteria
This trial is for adults aged 18-65 with relapsing-remitting Multiple Sclerosis who experience walking difficulties. They must be on stable medication, have no recent MS relapses or steroid use, and can travel to Boulder campus. Excluded are those with uncorrected vision/hearing issues, certain physical conditions, metal implants, major diseases like HIV/cancer, history of head injury/stroke/seizures/drug abuse/alcoholism.Inclusion Criteria
I am between 18 and 65 years old.
Able to read, understand, and speak English to ensure safe participation in the project
I have trouble walking.
+4 more
Exclusion Criteria
I have had a head injury or stroke in the past.
Metal implants
≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive TENS treatment or sham dose for 6 weeks, 3 times per week
6 weeks
18 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Participant Groups
The study tests if TENS (Transcutaneous electrical nerve stimulation) can reduce fatigue in people with MS. Participants will be randomly assigned to receive either the real TENS treatment or a sham (fake) version to compare effectiveness.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Effective doseExperimental Treatment1 Intervention
• The effective dose of TENS will be set at an intensity to elicit slight contractions in each target muscle, as we have done previously. It will be delivered as 5-Hz bursts (7 pulses at 100 Hz/burst) and applied during the light exercises. The applied current (\<20 mA) will differ slightly for each of the four muscle groups and will be determined while the person is standing. The current will be set at the beginning of every treatment session for both groups of participants.
Group II: Sham dosePlacebo Group1 Intervention
• The current intensity for the sham dose will be set at sensory threshold, which will be less than that used for the effective dose. After beginning each exercise set, the current for the sham dose will decay to 0 mA within 30 s. In a preliminary study that included a sham dose of TENS, we found that only two of the experienced dancers in the sham group detected the gradual decline in TENS current from its initial value slightly above motor threshold when performing prescribed exercises.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ColoradoBoulder, CO
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Who Is Running the Clinical Trial?
University of Colorado, BoulderLead Sponsor
References
Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia. [2023]We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.
Electrical stimulation therapy for pain and related symptoms in multiple sclerosis: A systematic review and meta-analysis. [2023]The effectiveness of electrical stimulation therapy (EST) for pain, depression, fatigue, disability, and quality of life in multiple sclerosis (MS) remains uncertain. This study aims to analyze and discuss the efficacy of various EST treatments in alleviating pain among MS patients.
A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the "COMBO-MS" trial. [2020]Fatigue is one of the most common and disabling chronic symptoms in multiple sclerosis (MS). Optimization of available treatments for MS-related fatigue has been stymied by lack of comparative effectiveness research that focuses on real-world treatment delivery methods and potential modification of treatment effect by other chronic MS symptoms or disability level. This report describes the design of a patient centered, comparative effectiveness trial of cognitive behavioral-therapy (CBT), modafinil, and combination therapy of both for fatigue in MS ("COMBO-MS").
Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. [2019]Fatigue is a common and debilitating feature of multiple sclerosis (MS) that remains without reliably effective treatment. Transcranial direct current stimulation (tDCS) is a promising option for fatigue reduction. We developed a telerehabilitation protocol that delivers tDCS to participants at home using specially designed equipment and real-time supervision (remotely supervised transcranial direct current stimulation (RS-tDCS)).
Sensory complaints of the upper extremities in multiple sclerosis: relative efficacy of nortriptyline and transcutaneous electrical nerve stimulation. [2013]The aim of this study was to evaluate the relative efficacy of nortriptyline and self-applied transcutaneous electrical nerve stimulation (TENS) in the treatment of pain and/or sensory complaints of the upper extremities in people with multiple sclerosis (MS).
Efficacy of the use of two simultaneously TENS devices for fibromyalgia pain. [2021]Fibromyalgia is characterized by a range of symptoms that include muscle pain, fatigue and sleep disorders. Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief. The purpose of the study was to evaluate the effectiveness and safety of the use of two simultaneously new TENS devices for fibromyalgia pain. After Ethics approval and informed consent, 39 patients were prospectively divided into three groups to evaluate TENS device, applied simultaneously in each patient: (1) at the lower back (perpendicular to the vertebrae canal, at the level of the 5th lumbar vertebrae) and (2) centrally above and below the space between the C7 and T1 spinous processes. The devices were applied for 20 min at 12-h interval during 7 consecutive days. For the placebo group (PG), the devices did not transmitted electrical stimulus. The single-TENS group (STG) (n = 13) had one active and one placebo TENS. The DTG applied both active TENS devices at the low back and cervical areas. Diclofenac was used as rescue analgesic. The efficacy measures were pain relief, reduction in use of daily analgesic tablets, quality of sleep and fatigue. The evaluation within groups revealed that patients from DPG refereed no pain relief when compared to their previous VAS pain score (8 cm, p > 0.05), while patients from the STG refereed improvement of 2.5 cm in the pain VAS (previous 8.5 cm compared to 6 cm after treatment) (p STG > PG (p
Efficacy and safety of amantadine for the treatment of fatigue in multiple sclerosis: a systematic review and meta-analysis. [2021]Background: Fatigue is a debilitating symptom of multiple sclerosis (MS) affecting at least 75% of patients. Amantadine has been tested for MS-related fatigue treatment but efficacy and safety remain unclear. Materials & methods: We performed a systematic review and meta-analysis of qualified literatures searched until 30 April 2020. Results: A total of 11 clinical trials were included. The meta-analysis revealed improvement of MS-related fatigue with amantadine treatment using the patients' subjective responses and validated fatigue scales. Conclusion: Amantadine is the most studied drug that has shown improvement of MS-related fatigue, with mild side effects and good tolerability. Larger studies using a standard measurement for MS-related fatigue are recommended to improve the quality of evidence. Safety and efficacy on long-term use needs further investigation.
[Therapeutic indications for managing symptoms: fatigue]. [2022]Fatigue is a common complaint in patients affected by multiple sclerosis. Its mechanisms are poorly understood and are likely diverse. The term "fatigue" has been used for asthenia at rest but also for fatigability during exercise. Amantadine is the only drug that has a proven therapeutic benefit in randomized, double blind, controlled trials. Inhibitors of serotonin re-uptake are used pragmatically because of the relationship between fatigue and depression. Aminopyridins may improve fatigability, mainly at the level of lower limbs.
Systematic review of efficacy of TENS for management of central pain in people with multiple sclerosis. [2018]Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy that can be used for central pain (CP) management without the side effects of pharmacological interventions. Currently, the efficacy of TENS for management of CP in people living with multiple sclerosis (MS) is considered questionable.
Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial. [2017]Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue severity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The 'Magnetic Cell Regeneration' system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3-4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and control group (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session which 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high 'placebo effect' of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.
Transcranial direct current stimulation: A glimmer of hope for multiple sclerosis fatigue? [2018]Multiple sclerosis (MS) is a neurological disease of the central nervous system characterized by inflammation, demyelination and neurodegeneration. Throughout the disease process, patients may complain of a panel of sensory, motor, cognitive and behavioral symptoms. Fatigue is a debilitating manifestation of central nervous system diseases with physical, cognitive and psychosocial dimensions. In MS, fatigue could be very frequent concerning up to 90% of patients and may have a drastic impact on their quality of life. Based on neuroimaging studies, a 'cortico-striato-thalamo-cortical' loop seems to underlie this symptom. Despite the availability of pharmacological molecules, the majority of them fail to bring satisfactory outcomes mainly because of the numerous related side-effects. Therefore, finding a safe, easy to implement, and effective alternative therapy is highly needed. These properties appear to match those of noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS). tDCS consists of placing two electrodes over cortical sites, such as those that take part in MS fatigue loop. Here, tDCS protocols targeting MS fatigue are revisited. Their short and long-term effects are discussed. The majority of the available protocols have applied 5 consecutive daily 20-min sessions of anodal tDCS over specific cortical sites and yielded beneficial effects on MS fatigue. Finally, the recent emergence of remotely supervised tDCS protocols are also tackled in this work aiming to address the future possibility of translating the current research data into routine clinical practice. This may lead to optimize patients' care and improve their quality of life.
Treatment with weak electromagnetic fields improves fatigue associated with multiple sclerosis. [2019]It is estimated that 75-90% of patients with multiple sclerosis (MS) experience fatigue at some point during the course of the disease and that in about half of these patients, subjective fatigue is a primary complaint. In the majority of patients fatigue is present throughout the course of the day being most prominent in the mid to late afternoon. Sleepiness is not prominent, but patients report that rest may attenuate fatigability. The pathophysiology of the fatigue of MS remains unknown. Delayed impulse conduction in demyelinated zones may render transmission in the brainstem reticular formation less effective. In addition, the observation that rest may restore energy and that administration of pemoline and amantadine, which increase the synthesis and release of monoamines, often improve the fatigue of MS suggest that depletion of neurotransmitter stores in damaged neurons may contribute significantly to the development of fatigue in these patients. The present report concerns three MS patients who experienced over several years continuous and debilitating fatigue throughout the course of the day. Fatigue was exacerbated by increased physical activity and was not improved by rest. After receiving a course of treatments with picotesla flux electromagnetic fields (EMFs), which were applied extracranially, all patients experienced improvement in fatigue. Remarkably, patients noted that several months after initiation of treatment with EMFs they were able to recover, after a short period of rest, from fatigue which followed increased physical activity. These observations suggest that replenishment of monoamine stores in neurons damaged by demyelination in the brainstem reticular formation by periodic applications of picotesla flux intensity EMFs may lead to more effective impulse conduction and thus to improvement in fatigue including rapid recovery of fatigue after rest.