Clinical trial NCT03080454: The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Official title: The Effect of Treatment With the PathMaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients With Severe Hand Spasticity After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Cerebrovascular Accident (CVA)
Hemiparesis
Spasticity as Sequela of Stroke
Muscle Spasticity
Upper Extremity Paralysis
Keywords: stroke
CVA
Spasticity
hemiparesis
rehabilitation
trans-spinal direct current stimulation (tsDCS)
non-invasive stimulation
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: PathMaker Neurosystems Inc.
name: Dr. Zaghloul Ahmed
First posted: 2017-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
2. Cognitive function sufficient to understand the experiments and follow instructions
3. A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles
4. A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position

Exclusion Criteria:

1. Focal brainstem or thalamic infarcts
2. Prior surgical treatments for spasticity of the upper limb
3. Ongoing use of central nervous system (CNS)-active medications
4. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
5. Botox or phenol alcohol treatment within 12 weeks of enrollment
6. Pregnancy in women, as determined by self-report
7. History of spinal cord injury or weakness
8. Chronic pain
9. Peripheral neuropathy including insulin dependent diabetes as determined by case history
10. Presence of additional potential tsDCS risk factors:

    * Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
    * Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
    * Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
    * Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months

Primary outcomes:
measure: Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
timeFrame: baseline, final session at day 5, 1 week FU
Secondary outcomes:
measure: Mean Modified Tardieu Scale (MTS) Score
timeFrame: baseline, final session at day 5, 1 week FU
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.