Middle Cerebral Artery StrokeNCT04000269
HD-tDCs to Improve Upper Extremity Function in Patients With Acute Middle Cerebral Artery Stroke
A study testing Soterix MxN Neuromodulation device in people with Middle Cerebral Artery Stroke, run by Milton S. Hershey Medical Center.
Trial summary
To determine if using targeted high definition transcranial direct current stimulation can improve upper extremity motor function in patients with subacute middle cerebral artery (MCA) stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Middle Cerebral Artery Stroke
- What is being tested?
- Soterix MxN Neuromodulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2020to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-90 years old
- Diagnosed with middle cerebral artery ischemic stroke
- Upper extremity movement deficits
- Cardiorespiratory function is stable
- Admitted to acute inpatient rehabilitation
- Intact corticospinal tract
Who cannot join
- Previous stroke
- Pre-stoke weakness or disability in the paretic arm
- Severe neglect
- Acute exacerbation of heart failure or COPD
- Severe aphasia
- Decisional Impairment
Show all 10Show fewer
- Pregnant or nursing women
- Prisoner
- Skin disorder or wound of scalp
- Seizure disorder
About this study
Official title: Pilot Study Using Targeted High Definition Transcranial Direct Current Stimulation to Promote Upper Extremity Motor Function in Patients With Subacute Middle Cerebral Artery (MCA) Stroke
To determine if using targeted high definition transcranial direct current stimulation can improve upper extremity motor function in patients with subacute middle cerebral artery (MCA) stroke.
Read the detailed description
Current research suggests there may be potential benefit using high definition transcranial direct current stimulation in patients with upper extremity hemiparesis secondary to an ischemic stroke. The intervention has effects on the damaged neurons within the person's brain after stroke possibly amplifying the body's own healing process. These data are compelling but not always statistically significant, which could be due to several reasons. One is the lack of a definitive protocol involving timing of the intervention relative to therapy, lead placement, an unclear dose-response relationship, and variable conductance of tissue and skull thickness. Hummel et al (2008) suggested that stimulation during or before intensive therapy yielded improved motor function or reaction time than when no therapy was given around the stimulation. Several other review articles and studies suggest using both high definition tDCS, which increases the focality of the current, and/or using neurotargeting software that uses the patient's own CT/MRI in the computation of the electrical montage can create a more personalized tDCS regimen.7,11,12 This study plans to do both. The Soterix MxN neuromodulation system has been used in multiple studies and has a targeting system that would help ensure both ideal current, more focal stimulation and optimal lead placements is essential as according to Datta et al (2011). Lesions within the brain may alter the flow of current through that area. The software system, HD-Targets, will be used that takes the patient's own MRI to account for variabilities in skull thickness, lesion size/location/composition, fluid density, and cerebrospinal fluid presence. These variabilities are used in the computer algorithm that simulates current flow through that specific participant's brain to get to the desired target area with the least amount of current and decreased stimulation of undesired areas. The investigators will examine these patients before and after treatment and compare the two groups, treatment group and sham group, after they receive 10 sessions of 20minutes along with their regular course of physical, occupational, or speech therapy over the course of their inpatient rehab stay.
Subjects will be given high definition transcranial direct current stimulation (tDCS) via a Soterix MxN HD-tDCS stimulator. This device is for investigational use only at this time and is not FDA approved. However, it has been used in several multicenter and randomized control trials that are detailed below in Appendix 1. The patient's MRi will be sent out to Soterix where they will manually input the variations in skull thickness, fluid density, lesion size, cerebrospinal fluid, and gray/white matter variabilities. They will then run the algorithm with HD-Targets, sophisticated current simulating software, to obtain optimal electrode placement to target the primary motor cortex (M1 area), the region of the brain that is responsible for movement, of each individual patient. Another issue with tDCs is maintaining optimal connections between the patient's scalp and the electrodes. Sotetrix HD-tDCs uses SmartScan™ to assure proper lead contact with initial set-up to adjust electrodes and head-gear for optimal fit. During stimulation, SmartScan™ provides a constant indication of electrode quality and can be monitored during adjustments to assure continuous lead contact.
- Conditions
- Middle Cerebral Artery Stroke
- Being tested
- Soterix MxN Neuromodulation device, Sham Stimulation
- Medical subject headings
- Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix MxN Neuromodulation deviceDevice
Up to 2 mA stimulation to primary motor cortex for 10 sessions at 20min per session
Sham StimulationDevice
Uses slight stimulation initially then turns of and provides no stimulation after a few seconds.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with 'Soterix MxN Neuromodulation device (high definition transcranial direct current stimulator) using HD-Targets for optimal neural targeting will be provided to participants and will include 20 minutes of stimulation coupled with conventional OT treatment during and after the intervention. There will be a total of 10 sessions over about a 2 week period. Receives: Device: Soterix MxN Neuromodulation device |
| Sham group | Sham comparator | Sham stimulation will consist of using the devices auto-sham feature. The exact same setup/device will be used during both groups. This is considered a control for the experiment. Both groups will receive similar physical occupational and speech therapy Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fugl-Meyer upper extremity assessment
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It measures performances on motor function of the upper extremity. Range is from 0-66 with 66 being totally normal in all assessments. Each Sub score for each category ranges from 0-2 with 0 being not able to finish and 2 meaning function is normal in this category.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Secondary outcomes (8)
Change in the Wolf Motor Function Test
Quantifies upper extremity (UE) motor ability through timed and functional tasks. Thus, it measures how well a task can be performed by the subject, and the patient is given a score from 0-6. Zero being did not perform, and six being normal. The changes in performance can be compared over time to assess their progress. Each task is subscaled from 0-6 with 6 being indepednetly performed and 0 being unable to perform or needs to be performed by someone else for the patient.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in the Functional Independence Measure
A uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps for use in the medical system in the United States. It is a measure of a person's physical, psychological, and social functions to assess their level of disability. It is a scale from 18-126 with a score of 126 being completely normal or independent in all of the tasks. 17 tasks in total: 6 are functional tasks, 2 measure strength, and 9 analyze movement quality or efficiency. Each task is subscored from 1-7 with 7 being completely independent completing a task and 1 meaning the person is fully dependent on someone completing that task for them.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in the Action Research Arm Test
Evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). This measures 19 items covering four domains of upper extremity movement: grasp, grip, pinch, and gross motor. Score ranges from 0-57 with 57 being normal function in all domains. Each task has a subscore of 0-3 with 0 being unable to perform movement and 3 being normal function.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change arm speed
Developed by Robert Sainburg. The machine is able to measure how fast a patient's arm is able to move through space. Speed would be quantified as the peak and/or average tangential velocity of the hand during self-paced reaching movements.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change in arm smoothness
Developed by Robert Sainburg. The machine is able to measure how smooth a patient is able to move their arm through space. Smoothness is measured as mean squared Jerk: This is quantified as the third derivative of displacement (jerk) squared and averaged over time.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change in arm range of motion
Developed by Robert Sainburg. The machine is able to measure range of motion that would be quantified as the largest 2D area encircled by the hand, when asked to make the biggest circle possible. .
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in National institute of Health Stroke Scale
15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. Range of scores from 0-42 with zero being no symptoms and 42 being severely impaired. It is a way to quantify stroke severity with measures for the typical stroke symptoms including level on consciousness, language, vision, motor and sensory involvement, as well as some cognitive assessments.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in Modified Rankin Scale
Single item, global outcomes rating scale for patients post-stroke. Range is from 0-6. Zero being no symptoms and 6 being dead. In-between measures consist of how much help they require during their activities of daily living.
Measured: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start5 Jul 2020 (estimated)
- Primary completion5 Sep 2022 (estimated)
- Study completion5 Sep 2022 (estimated)
Why it stopped: Did not receive IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Middle Cerebral Artery StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot prospective double blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William A Pomilla, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000269
- Sponsor's protocol ID
- None at this time
- Status last verified
- Mar 2022
- First submitted
- 1 Apr 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying data will be distributed. Demographic information with used within the groups to assess treatment versus sham homogenicity
Publications
Di Pino G, Pellegrino G, Assenza G, Capone F, Ferreri F, Formica D, Ranieri F, Tombini M, Ziemann U, Rothwell JC, Di Lazzaro V. Modulation of brain plasticity in stroke: a novel model for neurorehabilitation. Nat Rev Neurol. 2014 Oct;10(10):597-608. doi: 10.1038/nrneurol.2014.162. Epub 2014 Sep 9.
PubMed 25201238Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
PubMed 21343407Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
PubMed 12949224Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Elsner B, Kwakkel G, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving capacity in activities and arm function after stroke: a network meta-analysis of randomised controlled trials. J Neuroeng Rehabil. 2017 Sep 13;14(1):95. doi: 10.1186/s12984-017-0301-7.
PubMed 28903772Giordano J, Bikson M, Kappenman ES, Clark VP, Coslett HB, Hamblin MR, Hamilton R, Jankord R, Kozumbo WJ, McKinley RA, Nitsche MA, Reilly JP, Richardson J, Wurzman R, Calabrese E. Mechanisms and Effects of Transcranial Direct Current Stimulation. Dose Response. 2017 Feb 9;15(1):1559325816685467. doi: 10.1177/1559325816685467. eCollection 2017 Jan-Mar.
PubMed 28210202Rabadi MH, Aston CE. 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. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S178-S184. doi: 10.1097/PHM.0000000000000823.
PubMed 28837443Kang N, Summers JJ, Cauraugh JH. Transcranial direct current stimulation facilitates motor learning post-stroke: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2016 Apr;87(4):345-55. doi: 10.1136/jnnp-2015-311242. Epub 2015 Aug 28.
PubMed 26319437Hummel FC, Celnik P, Pascual-Leone A, Fregni F, Byblow WD, Buetefisch CM, Rothwell J, Cohen LG, Gerloff C. Controversy: Noninvasive and invasive cortical stimulation show efficacy in treating stroke patients. Brain Stimul. 2008 Oct;1(4):370-82. doi: 10.1016/j.brs.2008.09.003. Epub 2008 Oct 9.
PubMed 20633395Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.
PubMed 26652115Nitsche MA, Grundey J, Liebetanz D, Lang N, Tergau F, Paulus W. Catecholaminergic consolidation of motor cortical neuroplasticity in humans. Cereb Cortex. 2004 Nov;14(11):1240-5. doi: 10.1093/cercor/bhh085. Epub 2004 May 13.
PubMed 15142961Monte-Silva K, Kuo MF, Thirugnanasambandam N, Liebetanz D, Paulus W, Nitsche MA. Dose-dependent inverted U-shaped effect of dopamine (D2-like) receptor activation on focal and nonfocal plasticity in humans. J Neurosci. 2009 May 13;29(19):6124-31. doi: 10.1523/JNEUROSCI.0728-09.2009.
PubMed 19439590Kuo MF, Unger M, Liebetanz D, Lang N, Tergau F, Paulus W, Nitsche MA. Limited impact of homeostatic plasticity on motor learning in humans. Neuropsychologia. 2008;46(8):2122-8. doi: 10.1016/j.neuropsychologia.2008.02.023. Epub 2008 Feb 29.
PubMed 18394661
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Targeted High Definition Transcranial Direct Current Stimulation to Promote Upper Extremity Motor Function in Patients With Subacute Middle Cerebral Artery (MCA) Stroke
- ClinicalTrials.gov ID
- NCT04000269
- Acronym / sponsor ID
- None at this time
- Conditions
- Middle Cerebral Artery Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2020 (estimated)
- Primary completion
- 5 Sep 2022 (estimated)
- Study completion
- 5 Sep 2022 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if using targeted high definition transcranial direct current stimulation can improve upper extremity motor function in patients with subacute middle cerebral artery (MCA) stroke.
Detailed description
Current research suggests there may be potential benefit using high definition transcranial direct current stimulation in patients with upper extremity hemiparesis secondary to an ischemic stroke. The intervention has effects on the damaged neurons within the person's brain after stroke possibly amplifying the body's own healing process. These data are compelling but not always statistically significant, which could be due to several reasons. One is the lack of a definitive protocol involving timing of the intervention relative to therapy, lead placement, an unclear dose-response relationship, and variable conductance of tissue and skull thickness. Hummel et al (2008) suggested that stimulation during or before intensive therapy yielded improved motor function or reaction time than when no therapy was given around the stimulation. Several other review articles and studies suggest using both high definition tDCS, which increases the focality of the current, and/or using neurotargeting software that uses the patient's own CT/MRI in the computation of the electrical montage can create a more personalized tDCS regimen.7,11,12 This study plans to do both. The Soterix MxN neuromodulation system has been used in multiple studies and has a targeting system that would help ensure both ideal current, more focal stimulation and optimal lead placements is essential as according to Datta et al (2011). Lesions within the brain may alter the flow of current through that area. The software system, HD-Targets, will be used that takes the patient's own MRI to account for variabilities in skull thickness, lesion size/location/composition, fluid density, and cerebrospinal fluid presence. These variabilities are used in the computer algorithm that simulates current flow through that specific participant's brain to get to the desired target area with the least amount of current and decreased stimulation of undesired areas. The investigators will examine these patients before and after treatment and compare the two groups, treatment group and sham group, after they receive 10 sessions of 20minutes along with their regular course of physical, occupational, or speech therapy over the course of their inpatient rehab stay.
Subjects will be given high definition transcranial direct current stimulation (tDCS) via a Soterix MxN HD-tDCS stimulator. This device is for investigational use only at this time and is not FDA approved. However, it has been used in several multicenter and randomized control trials that are detailed below in Appendix 1. The patient's MRi will be sent out to Soterix where they will manually input the variations in skull thickness, fluid density, lesion size, cerebrospinal fluid, and gray/white matter variabilities. They will then run the algorithm with HD-Targets, sophisticated current simulating software, to obtain optimal electrode placement to target the primary motor cortex (M1 area), the region of the brain that is responsible for movement, of each individual patient. Another issue with tDCs is maintaining optimal connections between the patient's scalp and the electrodes. Sotetrix HD-tDCs uses SmartScan™ to assure proper lead contact with initial set-up to adjust electrodes and head-gear for optimal fit. During stimulation, SmartScan™ provides a constant indication of electrode quality and can be monitored during adjustments to assure continuous lead contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Pilot prospective double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Soterix MxN Neuromodulation deviceTreatment with 'Soterix MxN Neuromodulation device (high definition transcranial direct current stimulator) using HD-Targets for optimal neural targeting will be provided to participants and will include 20 minutes of stimulation coupled with conventional OT treatment during and after the intervention. There will be a total of 10 sessions over about a 2 week period. |
| Sham group | Sham comparator | Device: Sham StimulationSham stimulation will consist of using the devices auto-sham feature. The exact same setup/device will be used during both groups. This is considered a control for the experiment. Both groups will receive similar physical occupational and speech therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18-90 years old
- Diagnosed with middle cerebral artery ischemic stroke
- Upper extremity movement deficits
- Cardiorespiratory function is stable
- Admitted to acute inpatient rehabilitation
Key exclusion criteria (10 listed)
- Previous stroke
- Pre-stoke weakness or disability in the paretic arm
- Severe neglect
- Acute exacerbation of heart failure or COPD
- Severe aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soterix MxN Neuromodulation deviceUp to 2 mA stimulation to primary motor cortex for 10 sessions at 20min per session | Device | Treatment Group |
| Sham StimulationUses slight stimulation initially then turns of and provides no stimulation after a few seconds. | Device | Sham group |
Primary outcome
Change in the Fugl-Meyer upper extremity assessment
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It measures performances on motor function of the upper extremity. Range is from 0-66 with 66 being totally normal in all assessments. Each Sub score for each category ranges from 0-2 with 0 being not able to finish and 2 meaning function is normal in this category.
8 secondary outcomes
Change in the Wolf Motor Function Test
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in the Functional Independence Measure
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in the Action Research Arm Test
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change arm speed
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change in arm smoothness
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Kinematic measurements with Kinereach system: measurement of change in arm range of motion
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in National institute of Health Stroke Scale
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Change in Modified Rankin Scale
Time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 25201238Di Pino G, Pellegrino G, Assenza G, Capone F, Ferreri F, Formica D, Ranieri F, Tombini M, Ziemann U, Rothwell JC, Di Lazzaro V. Modulation of brain plasticity in stroke: a novel model for neurorehabilitation. Nat Rev Neurol. 2014 Oct;10(10):597-608. doi: 10.1038/nrneurol.2014.162. Epub 2014 Sep 9.
- Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
- Background: PubMed 21343407Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
- Background: PubMed 12949224Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
- Background: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Background: PubMed 28903772Elsner B, Kwakkel G, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving capacity in activities and arm function after stroke: a network meta-analysis of randomised controlled trials. J Neuroeng Rehabil. 2017 Sep 13;14(1):95. doi: 10.1186/s12984-017-0301-7.
- Background: PubMed 28210202Giordano J, Bikson M, Kappenman ES, Clark VP, Coslett HB, Hamblin MR, Hamilton R, Jankord R, Kozumbo WJ, McKinley RA, Nitsche MA, Reilly JP, Richardson J, Wurzman R, Calabrese E. Mechanisms and Effects of Transcranial Direct Current Stimulation. Dose Response. 2017 Feb 9;15(1):1559325816685467. doi: 10.1177/1559325816685467. eCollection 2017 Jan-Mar.
- Background: PubMed 28837443Rabadi MH, Aston CE. 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. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S178-S184. doi: 10.1097/PHM.0000000000000823.
- Background: PubMed 26319437Kang N, Summers JJ, Cauraugh JH. Transcranial direct current stimulation facilitates motor learning post-stroke: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2016 Apr;87(4):345-55. doi: 10.1136/jnnp-2015-311242. Epub 2015 Aug 28.
- Background: PubMed 20633395Hummel FC, Celnik P, Pascual-Leone A, Fregni F, Byblow WD, Buetefisch CM, Rothwell J, Cohen LG, Gerloff C. Controversy: Noninvasive and invasive cortical stimulation show efficacy in treating stroke patients. Brain Stimul. 2008 Oct;1(4):370-82. doi: 10.1016/j.brs.2008.09.003. Epub 2008 Oct 9.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- Background: PubMed 26652115Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.
- Individual participant dataSharing planned: No. No identifying data will be distributed. Demographic information with used within the groups to assess treatment versus sham homogenicity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A Pomilla, MD principal investigator
Assistant Professor
Questions about this trial
What is this clinical trial studying?
A study testing Soterix MxN Neuromodulation device in people with Middle Cerebral Artery Stroke, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Fugl-Meyer upper extremity assessment (time frame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000269, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.