We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080454
Recruitment Status : Completed
First Posted : March 15, 2017
Results First Posted : September 13, 2019
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
PathMaker Neurosystems Inc.
Dr. Zaghloul Ahmed
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident (CVA) Hemiparesis Spasticity as Sequela of Stroke Muscle Spasticity Upper Extremity Paralysis Device: sham Doublestim Device: anodal Doublestim Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
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 Start Date : September 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Sham Doublestim
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
PathMaker MyoRegulator device
Other Name: sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)
Active Comparator: Anodal Doublestim
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
PathMaker MyoRegulator device
Other Name: anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed [ Time Frame: baseline, final session at day 5, 1 week FU ]
    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)


Secondary Outcome Measures :
  1. Mean Modified Tardieu Scale (MTS) Score [ Time Frame: baseline, final session at day 5, 1 week FU ]
    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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080454


Locations
Layout table for location information
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
PathMaker Neurosystems Inc.
Dr. Zaghloul Ahmed
  Study Documents (Full-Text)

Documents provided by Bruce Volpe, Northwell Health:
Study Protocol and Statistical Analysis Plan  [PDF] August 18, 2017
Informed Consent Form  [PDF] August 18, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03080454    
Other Study ID Numbers: 15-110
First Posted: March 15, 2017    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: April 5, 2021
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruce Volpe, Northwell Health:
stroke
CVA
Spasticity
hemiparesis
 rehabilitation
trans-spinal direct current stimulation (tsDCS)
non-invasive stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Stroke
Paralysis
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations