The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080454
• Other study ID #: 15-110
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2019
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident (CVA)
• Hemiparesis
• Muscle Spasticity
• Paralysis
• Paresis
• Spasticity as Sequela of Stroke
• Stroke
• Upper Extremity Paralysis

Intervention

Device:
• sham Doublestim
PathMaker MyoRegulator device
• anodal Doublestim
PathMaker MyoRegulator device

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	Dr. Zaghloul Ahmed, PathMaker Neurosystems Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Ahmed Z. Trans-spinal direct current stimulation modifies spinal cord excitability through synaptic and axonal mechanisms. Physiol Rep. 2014 Sep 28;2(9). pii: e12157. doi: 10.14814/phy2.12157. Print 2014 Sep 1. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	baseline, final session at day 5, 1 week FU
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).	baseline, final session at day 5, 1 week FU