tDCS + CCFES for Stroke-related Hand Weakness
Recruiting in Palo Alto (17 mi)
Overseen byDavid A Cunningham, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: MetroHealth Medical Center
Must not be taking: Seizure medications
Disqualifiers: Neurological conditions, Seizure disorder, Pregnant, others
No Placebo Group
Trial Summary
What is the purpose of this trial?After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement.
The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on medications that lower the seizure threshold, you may not be eligible to participate.
What data supports the effectiveness of this treatment for stroke-related hand weakness?
Research shows that transcranial direct current stimulation (tDCS) can improve arm and hand function in stroke patients when combined with physical and occupational therapy. Studies have found that different tDCS setups can lead to significant improvements in upper limb function, suggesting that tDCS may enhance rehabilitation outcomes for stroke-related hand weakness.
12345Is tDCS + CCFES safe for humans?
Transcranial Direct Current Stimulation (tDCS) is generally considered safe for humans when used at an intensity of 4 mA or less for up to 60 minutes per day, with no severe complications reported in studies. However, it can cause mild skin irritation, and caution is advised, especially for vulnerable groups like children and the elderly.
678910What makes the tDCS + CCFES treatment for stroke-related hand weakness unique?
This treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with contralaterally controlled functional electrical stimulation (CCFES), which helps improve hand function by stimulating the muscles directly. This dual approach aims to enhance motor recovery more effectively than traditional therapies alone.
12111213Eligibility Criteria
This trial is for adults aged 21-90 who've had a stroke within the last 6-24 months, resulting in upper limb weakness but can still open their hand somewhat. They must be able to follow commands, remember things short-term, and sit unassisted. Excluded are those with seizure disorders, other neurological conditions, implanted electronic devices, pregnancy, recent Botox injections in the arm muscles or severe cognitive impairments.Inclusion Criteria
I can move my shoulder and elbow enough to use my hand for table tasks.
I have weakness in one arm, making it hard to fully extend my fingers.
You have a specific score on a test that measures hand movement ability.
+11 more
Exclusion Criteria
I cannot feel my arm, forearm, or hand.
I cannot move my hand or shoulder without severe pain.
I have severe difficulties in thinking and communicating.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one of three tDCS protocols combined with CCFES-mediated occupational therapy for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 weeks
Participant Groups
The study tests three types of non-invasive brain stimulation combined with occupational therapy to improve hand movement after a stroke. Participants will receive either conventional tDCS (transcranial direct current stimulation), unconventional tDCS montages plus CCFES (Contralaterally Controlled Functional Electrical Stimulation), or sham tDCS plus CCFES.
3Treatment groups
Active Control
Placebo Group
Group I: Active conventional tDCS plus CCFESActive Control2 Interventions
The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
Group II: Active unconventional tDCS plus CCFESActive Control2 Interventions
The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
Group III: Sham tDCS plus CCFESPlacebo Group2 Interventions
The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.
Active conventional tDCS montage plus CCFES is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Direct Current Stimulation for:
- Post-stroke upper extremity hemiplegia
- Motor function rehabilitation
🇪🇺 Approved in European Union as Transcranial Direct Current Stimulation for:
- Post-stroke motor function rehabilitation
- Neurological rehabilitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroHealth Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
MetroHealth Medical CenterLead Sponsor
References
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.
Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial. [2022]The aim of this article was to determine whether cathodal transcranial direct current stimulation (c-tDCS) to unaffected primary motor cortex (PMC) plus conventional occupational therapy (OT) improves functional motor recovery of the affected arm hand in patients after an acute ischemic stroke compared with sham transcranial direct current stimulation plus conventional OT.
Transcranial direct current stimulation: electrode montage in stroke. [2016]Neurophysiological and computer modelling studies have shown that electrode montage is a critical parameter to determine the neuromodulatory effects of transcranial direct current stimulation (tDCS). We tested these results clinically by systematically investigating optimal tDCS electrode montage in stroke. Ten patients received in a counterbalanced and randomised order the following conditions of stimulation (i) anodal stimulation of affected M1 (primary motor cortex) and cathodal stimulation of unaffected M1 ('bilateral tDCS'); (ii) anodal stimulation of affected M1 and cathodal stimulation of contralateral supraorbital area ('anodal tDCS'); (iii) cathodal stimulation of unaffected M1 and anodal stimulation of contralateral supraorbital area ('cathodal tDCS'); (iv) anodal stimulation of affected M1 and cathodal stimulation of contralateral deltoid muscle ('extra-cephalic tDCS') and (v) sham stimulation. We used the Jebsen-Taylor Test (JTT) as a widely accepted measure of upper limb function. Bilateral tDCS, anodal tDCS and cathodal tDCS were shown to be associated with significant improvements on the JTT. Placing the reference electrode in an extracephalic position and use of sham stimulation did not induce any significant effects. This small sham controlled cross-over clinical trial is important to provide additional data on the clinical effects of tDCS in stroke and for planning and designing future large tDCS trials in patients with stroke.
Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. [2018]Transcranial direct current stimulation may enhance effect of rehabilitation in patients with chronic stroke. The objective was to evaluate the efficacy of anodal transcranial direct current stimulation combined with constraint-induced movement therapy of the paretic upper limb.
Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]High-definition transcranial direct current stimulation (HD-tDCS) may allow more specific neural modulation than conventional-tDCS.
Differences in the experience of active and sham transcranial direct current stimulation. [2021]A limited number of studies have shown that modulation of cortical excitability using transcranial direct current stimulation (tDCS) is safe and tolerable. Few have directly evaluated whether sham and active stimulation are indistinguishable.
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.
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.
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.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
Combined Brain and Peripheral Nerve Stimulation in Chronic Stroke Patients With Moderate to Severe Motor Impairment. [2022]To evaluate effects of somatosensory stimulation in the form of repetitive peripheral nerve sensory stimulation (RPSS) in combination with transcranial direct current stimulation (tDCS), tDCS alone, RPSS alone, or sham RPSS + tDCS as add-on interventions to training of wrist extension with functional electrical stimulation (FES), in chronic stroke patients with moderate to severe upper limb impairments in a crossover design. We hypothesized that the combination of RPSS and tDCS would enhance the effects of FES on active range of movement (ROM) of the paretic wrist to a greater extent than RPSS alone, tDCS alone or sham RPSS + tDCS.
Combined transcranial direct current stimulation and home-based occupational therapy for upper limb motor impairment following intracerebral hemorrhage: a double-blind randomized controlled trial. [2016]To investigate the combined effect of transcranial direct current stimulation (tDCS) and home-based occupational therapy on activities of daily living (ADL) and grip strength, in patients with upper limb motor impairment following intracerebral hemorrhage (ICH).
Functional Brain Stimulation in a Chronic Stroke Survivor With Moderate Impairment. [2018]To determine the impact of transcranial direct current stimulation (tDCS) combined with repetitive, task-specific training (RTP) on upper-extremity (UE) impairment in a chronic stroke survivor with moderate impairment.