Brain & Muscle Stimulation for Stroke Rehabilitation
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?This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold, as decided by the study physician.
What data supports the effectiveness of this treatment for stroke rehabilitation?
Research shows that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, is associated with significant motor function improvement in stroke patients, especially when used in repeated sessions.
12345Is transcranial direct current stimulation (tDCS) 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 over 33,200 sessions. However, it can cause mild skin irritation, and caution is advised for potentially vulnerable groups like children and the elderly.
678910How is the treatment 'Brain & Muscle Stimulation for Stroke Rehabilitation' different from other stroke rehabilitation treatments?
This treatment uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a small electrical current to the brain to enhance motor recovery and improve daily living activities after a stroke, which is different from traditional physical therapies that do not involve direct brain stimulation.
511121314Eligibility Criteria
This trial is for stroke survivors over 21 years old with chronic upper limb hemiplegia, who can follow commands and have some finger movement. They must be medically stable, able to sit unassisted, and at least 6 months post-stroke. Excluded are pregnant individuals, those with other neurological conditions or severe pain in the affected limb, recent botox injections in the arm muscles, certain metal implants or electronic devices.Inclusion Criteria
I can fully move and use my unaffected arm and hand.
I can follow complex instructions and remember things well.
Medically stable
+9 more
Exclusion Criteria
I cannot move my hand or shoulder without severe pain.
I have seizures that are not controlled by medication.
I have a neurological condition besides a past stroke affecting my arm.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive non-invasive brain stimulation and neuromuscular electrical stimulation to improve hand motor control
6 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how non-invasive brain stimulation (tDCS) combined with functional electrical stimulation affects hand motor control in stroke patients. It explores optimal timing and delivery methods of these treatments to improve hand function.
5Treatment groups
Experimental Treatment
Placebo Group
Group I: unconventional tDCS preceding CCFESExperimental Treatment1 Intervention
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Group II: unconventional tDCS concurrent with CCFESExperimental Treatment1 Intervention
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Group III: conventional tDCS preceding CCFESExperimental Treatment1 Intervention
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Group IV: conventional tDCS concurrent with CCFESExperimental Treatment1 Intervention
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Group V: sham tDCS with CCFESPlacebo Group1 Intervention
sham tDCS preceding and concurrent with CCFES
electrical stimulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:
- Stroke rehabilitation
- Motor disorders
🇪🇺 Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:
- Stroke rehabilitation
- Motor disorders
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
Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. [2021]Proof-of-principle studies have demonstrated transient beneficial effects of transcranial direct current stimulation (tDCS) on motor function in stroke patients, mostly after single treatment sessions.
Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. [2022]Recent evidence has suggested that a simple technique of noninvasive brain stimulation - transcranial direct current stimulation (tDCS) - is associated with a significant motor function improvement in stroke patients.
Transcranial direct current stimulation in stroke recovery. [2022]Transcranial direct current stimulation (TDCS) is an emerging technique of noninvasive brain stimulation that has been found useful in examining cortical function in healthy subjects and in facilitating treatments of various neurologic disorders. A better understanding of adaptive and maladaptive poststroke neuroplasticity and its modulation through noninvasive brain stimulation has opened up experimental treatment options using TDCS for patients recovering from stroke. We review the role of TDCS as a facilitator of stroke recovery, the different modes of TDCS, and the potential mechanisms underlying the neural effects of TDCS.
Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. [2020]To explore the effects of transcranial direct current stimulation (tDCS) on the motor recovery of stroke patients and the effect differences between the upper limb and lower limb.
tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique, which can modulate cortical excitability and combined with rehabilitation therapies may improve motor recovery after stroke.
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 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 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.
A safety study of 500 μA cathodal transcranial direct current stimulation in rat. [2020]Transcranial direct current stimulation (tDCS) is a noninvasive neural control technology that has become a research hotspot. To facilitate further research of tDCS, the biosafety of 500 μA cathodal tDCS, a controversial parameter in rats was evaluated.
Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. [2018]Transcranial direct current stimulation (tDCS) is a technique for brain modulation that has potential to be used in motor neurorehabilitation. Considering that the cerebellum and motor cortex exert influence on the motor network, their stimulation could enhance motor functions, such as motor imagery, and be utilized for brain-computer interfaces (BCIs) during motor neurorehabilitation.
Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. [2023]Stroke is one of the leading causes of disability worldwide. Functional impairment, resulting in poor performance in activities of daily living (ADLs) among stroke survivors is common. Current rehabilitation approaches have limited effectiveness in improving ADL performance, function, muscle strength and cognitive abilities (including spatial neglect) after stroke, but a possible adjunct to stroke rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve ADL performance, arm and leg function, muscle strength and cognitive abilities (including spatial neglect), dropouts and adverse events in people after stroke.
[Non-invasive direct current stimulation of the brain: a new technique for stroke rehabilitation]. [2018]Experimental studies suggest that the non-invasive brain stimulation technique transcranial direct current stimulation (tDCS) may potentiate rehabilitation following stroke and lead to improved motor function. This effect is believed to be due to correction of imbalanced interhemispheric inhibition. The results of recent trials are promising, but optimal stimulation paradigms are yet to be determined and further investigations are required, before tDCS can be recommended for stroke rehabilitation.
Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]Transcranial direct current stimulation (tDCS) is a technique for noninvasively stimulating specific cortical regions of the brain with small (