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| Name | Class |
|---|---|
| PathMaker Neurosystems Inc. | INDUSTRY |
| Dr. Zaghloul Ahmed | UNKNOWN |
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The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Doublestim | Placebo Comparator | Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition. |
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| Anodal Doublestim | Active Comparator | Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham Doublestim | Device | PathMaker MyoRegulator device |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed | Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim) | baseline, final session at day 5, 1 week FU |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Modified Tardieu Scale (MTS) Score | The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim). |
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Inclusion Criteria:
Exclusion Criteria:
Focal brainstem or thalamic infarcts
Prior surgical treatments for spasticity of the upper limb
Ongoing use of central nervous system (CNS)-active medications
Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Botox or phenol alcohol treatment within 12 weeks of enrollment
Pregnancy in women, as determined by self-report
History of spinal cord injury or weakness
Chronic pain
Peripheral neuropathy including insulin dependent diabetes as determined by case history
Presence of additional potential tsDCS risk factors:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24478352 | Background | Ahmed Z. Trans-spinal direct current stimulation alters muscle tone in mice with and without spinal cord injury with spasticity. J Neurosci. 2014 Jan 29;34(5):1701-9. doi: 10.1523/JNEUROSCI.4445-13.2014. | |
| 25263206 | Background | Ahmed Z. Trans-spinal direct current stimulation modifies spinal cord excitability through synaptic and axonal mechanisms. Physiol Rep. 2014 Sep 28;2(9):e12157. doi: 10.14814/phy2.12157. Print 2014 Sep 1. |
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All participants received both the anodal and sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS) conditions, and sequence of stimulation conditions was the same across participants, with sham stimulation preceding active stimulation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Doublestim, Then Anodal Doublestim | Participants underwent 2-3 baseline evaluations, then received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, sham FU measures were collected. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), and again underwent follow-up measures 1 week after the anodal intervention. For all participants, the sham condition preceded the anodal Doublestim condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2017 |
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All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.
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The sham stimulation condition preceded the anodal stimulation condition for all participants, and subjects were told they would receive both conditions, but were blinded to order of assignment.
| anodal Doublestim | Device | PathMaker MyoRegulator device |
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| baseline, final session at day 5, 1 week FU |
| 27932680 | Background | Samaddar S, Vazquez K, Ponkia D, Toruno P, Sahbani K, Begum S, Abouelela A, Mekhael W, Ahmed Z. Transspinal direct current stimulation modulates migration and proliferation of adult newly born spinal cells in mice. J Appl Physiol (1985). 2017 Feb 1;122(2):339-353. doi: 10.1152/japplphysiol.00834.2016. Epub 2016 Dec 8. |
| 20153248 | Background | Winkler T, Hering P, Straube A. Spinal DC stimulation in humans modulates post-activation depression of the H-reflex depending on current polarity. Clin Neurophysiol. 2010 Jun;121(6):957-61. doi: 10.1016/j.clinph.2010.01.014. Epub 2010 Feb 11. |
| 24970753 | Background | Bocci T, Vannini B, Torzini A, Mazzatenta A, Vergari M, Cogiamanian F, Priori A, Sartucci F. Cathodal transcutaneous spinal direct current stimulation (tsDCS) improves motor unit recruitment in healthy subjects. Neurosci Lett. 2014 Aug 22;578:75-9. doi: 10.1016/j.neulet.2014.06.037. Epub 2014 Jun 23. |
| 21576030 | Background | Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14. |
| 18786856 | Background | Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10. |
| 32232101 | Derived | Paget-Blanc A, Chang JL, Saul M, Lin R, Ahmed Z, Volpe BT. Non-invasive treatment of patients with upper extremity spasticity following stroke using paired trans-spinal and peripheral direct current stimulation. Bioelectron Med. 2019 Jul 23;5:11. doi: 10.1186/s42234-019-0028-9. eCollection 2019. |
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| NOT COMPLETED |
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| Sham Doublestim (5days) |
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| Sham FU (7days) |
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| Anodal Doublestim (5 Days) |
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| Anodal FU (7 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Doublestim, Then Anodal Doublestim | Crossover design study: Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed | Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim) | Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis. | Posted | Least Squares Mean | Standard Error | percent change | baseline, final session at day 5, 1 week FU |
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| Secondary | Mean Modified Tardieu Scale (MTS) Score | The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim). | Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | baseline, final session at day 5, 1 week FU |
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eight weeks for each subject
Safety population included all participants who enrolled in study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | Prior to any treatment interventions, participants performed 2-3 clinical and objective measure baseline evaluations. | 0 | 26 | 2 | 26 | 0 | 26 |
| EG001 | Sham Doublestim (5 Days) + Sham FU (7days) | Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Anodal Doublestim (5 Days) + Anodal FU (7days) | Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim. | 0 | 24 | 2 | 24 | 1 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotensive vasovagal event | Vascular disorders | Non-systematic Assessment | A hypotensive vasovagal event (fainting episode) that occurred during a baseline clinical evaluation prior to any treatment sessions. The subject was excluded from the study and the event was judged not related to the device. |
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| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Subject experienced an unrelated fall and hip fracture at home prior to receiving any stimulus in the study (sham or active), resulting in hospitalization and exclusion from the study. |
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| seizure | Nervous system disorders | Non-systematic Assessment | 2 subjects experienced a seizure 3-4 days after the fifth (final) active stimulation session. Both events were reported and deemed unrelated to study intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| persistent skin redness | Injury, poisoning and procedural complications | Systematic Assessment | Subject experienced moderate-severe neck redness immediately following stimulation, with persistent mild neck redness 24 later. Given the durability of her neck redness, the subject was excluded from the study by the PI. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Volpe | Feinstein Institute for Medical Research at Northwell Health | 516-562-3384 | bvolpe1@northwell.edu |
| May 29, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2017 | Mar 8, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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