TENS for Stroke
(TENS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Must not be taking: Amphetamines, CNS affecting, others
Disqualifiers: Neurological injury, Diabetes, Depression, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.
Will I have to stop taking my current medications?
If you are actively taking medications that affect the central nervous system or those that increase or decrease motor system excitability, you may need to stop them to participate in the trial. The protocol does not specify a washout period, but these medications are part of the exclusion criteria.
What data supports the effectiveness of the treatment Transcutaneous Electrical Nerve Stimulation (TENS) for stroke?
Research shows that TENS can help improve motor function, reduce muscle stiffness (spasticity), and enhance walking ability in stroke survivors. It is particularly effective when combined with physical exercises.
12345Is TENS generally safe for humans?
Research shows that TENS is generally safe for humans, with no side effects noted in studies involving childbirth and no adverse effects observed in mothers or newborns. However, it's important to use the correct settings to avoid any potential harm, especially near vital areas.
678910How is the TENS treatment different from other treatments for stroke?
TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it is a non-drug, non-invasive treatment that uses low-frequency electrical currents applied through the skin to help reduce pain and improve motor function after a stroke. Unlike other treatments, it is easy to use, inexpensive, and can be combined with exercise to enhance recovery.
12111213Eligibility Criteria
This trial is for post-stroke patients who have hemiplegia or paresis, which means they've lost some muscle control on one side of their body. Participants should be able to commit to at least 15 sessions over four months.Inclusion Criteria
* History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\> 6 months since onset)
* Ability to walk as part of activities of daily living
* Age between 18 and 80
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 session
1 visit (in-person)
Treatment
Participants undergo 15 sessions for testing changes in reflex behaviors, influence of descending motor tracts, and functional movement
4 months
15 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Optional Extension
Additional sessions for completing data collection or analyzing test-retest variability
Participant Groups
The study tests the effects of a Transcutaneous Electrical Nerve Stimulation (TENS) device called InTENSity 10 on stroke recovery. It involves various tests to see how it affects reflexes, motor neuron activity, and walking patterns after a stroke.
1Treatment groups
Experimental Treatment
Group I: Post Stroke - individuals with history of single unilateral stroke (>6 months since onset)Experimental Treatment1 Intervention
Individuals, aged 18-80, male or female, with a history of single unilateral stroke with subsequent lower limb hemiparesis on either side (\>6 months since onset)
Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as TENS for:
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
🇪🇺 Approved in European Union as TENS for:
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
🇨🇦 Approved in Canada as TENS for:
- Pain management
- Musculoskeletal pain
- Neck pain
- Back pain
- Knee osteoarthritis pain
- Overactive bladder
- Urinary retention
- Temporomandibular joint dysfunction
- Essential tremor
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. [2019]Transcutaneous electrical nerve stimulation (TENS) has been used to augment the efficacy of task-oriented training (TOT) after stroke. Bilateral intervention approaches have also been shown to be effective in augmenting motor function after stroke. The purpose of this study was to compare the efficacy of bilateral TENS combined with TOT versus unilateral TENS combined with TOT in improving lower-limb motor function in subjects with chronic stroke.
The effects of exercise with TENS on spasticity, balance, and gait in patients with chronic stroke: a randomized controlled trial. [2021]Transcutaneous electrical nerve stimulation (TENS) is a useful modality for pain control. TENS has recently been applied to decrease spasticity. The purpose of this study is to determine whether the addition of TENS to an exercise program reduces spasticity and improves balance and gait in chronic stroke patients.
Transcutaneous electrical nerve stimulation improves walking capacity and reduces spasticity in stroke survivors: a systematic review and meta-analysis. [2019]To evaluate (1) the effectiveness of transcutaneous electrical nerve stimulation (TENS) at improving lower extremity motor recovery in stroke survivors and (2) the optimal stimulation parameters for TENS.
[Efficiency of TENS treatment in hemiplegic shoulder pain: a placebo controlled study]. [2016]To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy on shoulder pain and upper extremity functions in hemiplegic patients.
Effects of transcutaneous electrical nerve stimulation alone or as additional therapy on chronic post-stroke spasticity: systematic review and meta-analysis of randomized controlled trials. [2021]Purpose: To evaluate the effects and to compare transcutaneous electrical nerve stimulation protocols, alone or as additional therapy in chronic post-stroke spasticity through a systematic review and meta-analysis of randomized clinical trials.Methods: Search was conducted in MEDLINE, Cochrane Library, EMBASE and Physiotherapy Evidence Database through November 2017 (CRD42015020146). Two independent reviewers performed articles selection, data extraction and methodological quality assessment using the Cochrane Collaboration's risk of bias tool. The main outcome was spasticity assessed with Modified Ashworth Scale or other valid scale. Meta-analysis was conducted using random effects method, and pooled-effect results are mean difference with 95% confidence interval.Results: Of 6506 articles identified, 10 studies with 360 subjects were included in the review. Transcutaneous electrical nerve stimulation alone or as additional therapy is superior to placebo TENS to reduce post-stroke spasticity assessed with Modified Ashworth Scale (-0.52 [-0.74 to -0.30] p < 0.0001, 6 studies), especially in lower limbs (-0.58 [-0.82 to -0.34] p < 0.0001, 5 studies), which is in accordance with the studies that used other scales. Low frequency TENS showed a slightly larger improvement than high-frequency, but without significant difference between subgroups. Most studies present low or unclear risk of bias.Conclusion: Transcutaneous electrical nerve stimulation can provide additional reduction in chronic post-stroke spasticity, mainly as additional therapy to physical interventions. Studies with better methodological quality and larger sample are needed to increase evidence power.Implications for RehabilitationTranscutaneous electrical nerve stimulation as additional treatment to physical interventions can lead to additional reduction in chronic post-stroke spasticity.High and low frequency transcutaneous electrical nerve stimulation showed similar results, with a smaller numerical superiority of low frequency TENS.More studies are needed to substantiate the best protocol of transcutaneous electrical nerve stimulation to the treatment of spasticity.
Effects of transcutaneous electrical nerve stimulation via peroneal nerve or soleus muscle on venous flow: A randomized cross-over study in healthy subjects. [2022]Transcutaneous electrical nerve stimulation (TENS) is used to prevent venous stasis and thromboembolism. However, best electrostimulation parameters have yet to be established. The aim of the study was to compare the hemodynamic effects and the participants' relative discomfort of 3 TENS sequences at the maximum tolerated intensity stimulus.
Low TENS treatment on post-stroke paretic arm: a three-year follow-up. [2017]To determine whether stroke patients with initial increases in arm motor recovery following low-frequency transcutaneous electrical nerve stimulation (low TENS) treatment go on to show long-term benefits. Also whether the same therapy results in long-term improvements in motor function, spasticity or activities of daily living (ADL).
The effect of electrical stimulation on impairment of the painful post-stroke shoulder. [2020]Background: Transcutaneous electrical nerve stimulation (TENS) and transcutaneous neuromuscular electrical stimulation (t-NMES) are commonly used therapies in the treatment of chronic hemiplegic shoulder pain. These treatments are often utilized during physical or occupational therapy sessions, yet research into the acute analgesic effects of TENS and t-NMES on hemiplegic shoulder pain and use during therapy is limited. Objective: To compare the acute effects of transcutaneous electrical nerve stimulation (TENS), transcutaneous neuromuscular electrical stimulation (t-NMES), and no stimulation on pain-free passive range of motion of the shoulder in subjects with hemiplegic shoulder pain. Methods: Prospective cohort study of 10 subjects randomly treated with t-NMES, TENS, and one non-stimulation experimental condition. Pain-free passive external rotation and abduction range of motion of the affected shoulder were measured during stimulation. Results: There was not a significant within-subject difference in pain-free range of motion for external rotation or abduction. Subject to subject differences explained the majority of the variability in pain-free range of motion. Conclusion: This pilot study is the first to measure pain-free passive range of motion during electrical stimulation. Our findings demonstrate the lack of an acute effect of TENS and t-NMES on pain reduction.
[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. [2011]The analgesic effect of transcutaneous electric nerve stimulation (TNS) during delivery has been studied. 57 (55.9%) of 102 women treated considered TNS had given them good or very good relief from pain; 24 (23.5%) reported that they had received some relief, while 21 patients (20.6%) were of the opinion that they were not helped by the technique. CTG monitoring ocurred in all cases. No side effects on the fetus or the mother have been noted. A positive aspect of TNS was the quick course of delivery and the absence of obstetrical complications in the cases treated with this method. Therefore the designation of TNS as a new, riskless, but effective technique for pain relief during childbirth seems justified.
Pain relief in labor by transcutaneous electrical nerve stimulation. Safety aspects. [2019]A current density standard for current shapes used in transcutaneous electrical nerve stimulation (TNS) must be established in order to avoid harmful effects. This is especially important when stimulating near vital structures such as the fetal heart. In the absence of an applicable standard, a preliminary safety norm is proposed, based on clinical experience during delivery and experimental measurements in the female bladder. Current densities due to TNS not exceeding 0.5 microamperemeter/mm2 are safe for the fetal heart. A stimulator and electrodes fulfilling the safety criteria proposed in this study have been tested. A filter which suppresses the electrical disturbances occurring during TNS, thereby permitting recording of the fetal heart rate during birth, has also been tested. TNS was given over both the low-back and suprapubic region. Results of clinical tests of the equipment during 15 supervised births are reported. No adverse effect in the mother or newborn infant were observed.
The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. [2022]Transcutaneous electrical nerve stimulation (TENS) consists of a generic application of low-frequency, pulsed electrical currents transmitted by electrodes through the skin surface. It is a therapeutic modality that is nonpharmacological, noninvasive, inexpensive, easy to use and widely applied in clinical practice.
Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. [2018]Hemiplegic shoulder pain is a frequent complication after stroke, leading to limited use of the affected arm. Neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) are two widely used interventions to reduce pain, but the comparative efficacy of these two modalities remains uncertain. The purpose of this research was to compare the immediate and retained effects of EMG-triggered NMES and TENS, both in combination with bilateral arm training, on hemiplegic shoulder pain and arm function of stroke patients.
Transcutaneous electrical nerve stimulation for acute pain. [2022]Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological agent, based on delivering low voltage electrical currents to the skin. TENS is used for the treatment of a variety of pain conditions.