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

NCT03080454 | Completed Phase 1 Results

• 1 other identifier: 15-110
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Modified Tardieu Scale (MTS) Score

  baseline, final session at day 5, 1 week FU

Study Arms (2)

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.

Device: sham Doublestim

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.

Device: anodal Doublestim

Interventions

sham Doublestim DEVICE

PathMaker MyoRegulator device

Also known as: sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)

Sham Doublestim

anodal Doublestim DEVICE

PathMaker MyoRegulator device

Also known as: anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)

Anodal Doublestim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Northwell Health: lead
• PathMaker Neurosystems Inc.: collaborator
• Dr. Zaghloul Ahmed: collaborator

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (8)

• 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.

  PMID: 24478352 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.

  PMID: 25263206 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.

  PMID: 27932680 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.

  PMID: 20153248 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.

  PMID: 24970753 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.

  PMID: 21576030 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.

  PMID: 18786856 BACKGROUND

• 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.

  PMID: 32232101 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Results Point of Contact

• Title: Bruce Volpe
• Organization: Feinstein Institute for Medical Research at Northwell Health

bvolpe1@northwell.edu

516-562-3384

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 15, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 5, 2021
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Locations

US (1)