Electrical and Direct Current Stimulation for Foot Drop
(tDCS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two types of electrical stimulation can assist individuals who struggle to lift their toes after a stroke. Participants will receive transcranial direct current stimulation (tDCS) on their scalp and functional electrical stimulation (FES) on their legs during physical therapy sessions. The researchers aim to determine if these combined treatments can improve foot movement and reduce foot drop. This trial suits those who experienced a stroke over six months ago, have difficulty lifting their toes, and can walk independently for 15 minutes without an ankle brace. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.
What prior data suggests that this protocol is safe for stroke patients with foot drop?
Previous studies have shown that both Functional Electrical Stimulation (FES) and Transcranial Direct Current Stimulation (tDCS) are safe. Research indicates that FES is generally well-tolerated. Specifically, a study on individuals with foot drop after a stroke found no severe side effects from various FES frequencies (Frontiers in Neurology). Another review supports FES as a non-invasive method to enhance foot movement (Springer).
For tDCS, research suggests it is safe, with only minor side effects such as slight itching or tingling on the scalp (News-Medical). A study found no serious issues when tDCS was applied at an intensity of 4 mA or less for 60 minutes (e-BNR). This aligns with the trial setup, where the intensity is maintained at 1 mA.
Overall, existing studies consider both treatments safe, with minimal risk of serious side effects.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for foot drop because they use electrical stimulation methods that target the nervous system in innovative ways. Functional Electrical Stimulation (FES) directly stimulates muscles to improve movement, while Transcranial Direct Current Stimulation (tDCS) targets the brain's motor cortex to enhance neuroplasticity, potentially leading to better muscle control. These approaches are different from the standard of care, such as ankle-foot orthoses (AFOs) or physical therapy, which primarily focus on mechanical support or general muscle strengthening. The combination of FES and tDCS offers a promising new way to potentially restore more natural movement and improve walking abilities faster and more effectively.
What evidence suggests that combining FES and tDCS could be effective for foot drop in stroke patients?
This trial will evaluate the effectiveness of combining Functional Electrical Stimulation (FES) with Transcranial Direct Current Stimulation (tDCS) for treating foot drop. Studies have shown that FES can improve movement in people with stroke-related foot drop by sending small electrical signals to weakened muscles, enhancing walking. Meanwhile, tDCS has shown promise in enhancing leg and ankle movement by applying gentle electrical currents to the brain. Some participants in this trial will receive FES and tDCS together, while others will receive FES with tDCS at subthreshold levels. Together, these treatments aim to help people with post-stroke foot drop lift their toes and move their ankles more easily.24678
Who Is on the Research Team?
Gregory Thielman, EdD
Principal Investigator
Saint Joseph's University
Are You a Good Fit for This Trial?
This trial is for people who have had a stroke and now have trouble lifting their toes when walking (foot drop). Participants should be able to join physical therapy sessions. People with certain medical devices or conditions that make electrical stimulation unsafe cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combined transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) twice weekly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Functional Electrical Stimulation (FES)
- Transcranial Direct Current Stimulation (tDCS)
Trial Overview
The study tests whether combining two types of mild electrical stimulation—one on the scalp (tDCS) and one on the leg (FES)—along with leg exercises, helps improve foot movement in stroke survivors more than standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, Utah, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was one mA for 60 minutes for the duration of the gait training delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks. The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.
The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, UT, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was set initially at one mA for 60 minutes and then for the duration of the gait training the machine was turned to subthreshold levels, delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks. The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saint Joseph's University, Philadelphia
Lead Sponsor
Citations
"Functional Electrical Stimulation for Foot Drop: A Narrative ...
Evidence supports FES as effective for improving mobility in individuals with stroke, multiple sclerosis, and other neuromotor conditions.
2.
southcarolinablues.com
southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/functional-neuromuscular-electrical-stimulation-robotic-assisted-rehabilitation-and-robotic-assisted-orthotics/Functional Neuromuscular Electrical Stimulation, Robotic- ...
The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have chronic foot drop who receive FES, the ...
Evaluating the Effect of Functional Electrical Stimulation Used ...
12 Functional electrical stimulation has been found to be an effective treatment to correct foot drop and improve walking in people with MS.4,13,14 People ...
Functional electrical stimulation and ankle foot orthoses ...
This meta-analysis shows, for the first time, that FES and AFO are statistically proven to have the same therapeutic effect on walking speed in CNS foot drop.
Functional electrical stimulation of the peroneal nerve ...
Functional electrical stimulation (FES) applied to the paretic peroneal nerve has positive clinical effects on foot drop secondary to stroke. Objective. To ...
Functional Electrical Stimulation (FES) in Adults with ... - PMC
These findings suggest that evaluation timelines may need to be extended and that outcome measures beyond foot clearance should be considered, ...
Efficacy of functional electrical stimulation at different ...
Objective: To compare the efficacy and safety of low, medium, and high-frequency functional electrical stimulation (FES) in post-stroke foot drop (FD) ...
8.
provider.healthybluenc.com
provider.healthybluenc.com/medpolicies/healthybluenc/active/mp_pw_a049573.htmlDME.00022 Functional Electrical Stimulation (FES)
There was significant improvement reported within both groups from baseline to 30 weeks in comfortable gait speed (95% CI for mean change, 0.11-0.17 m/s for ...
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