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Combined Brain and Peripheral Nerve Stimulation for Stroke

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ClinicalTrials.gov Identifier: NCT01907737
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Adriana Bastos Conforto, University of Sao Paulo General Hospital

Brief Summary:
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.

Condition or disease Intervention/treatment Phase
Stroke Other: Active tDCS Other: Active PNS Other: Sham tDCS Other: Sham PNS Not Applicable

Detailed Description:

The goal of this study is to compare the effects of FES in close association with either transcranial direct current stimulation (tDCS) alone, peripheral nerve stimulation (PNS)alone, tDCS + PNS or sham tDCS + sham PNS, in patients with moderate to severe upper limb weakness, in a cross-over design. The working hypothesis of this proof-of-principle study is that either tDCS or PNS will enhance effects of functional electrical stimulation (FES) to a greater extent than placebo tDCS and PNS, and that the combination of tDCS and PNS will further improve motor outcomes than either tDCS or PNS alone.

The interventions will consist of outpatient motor training of the paretic wrist with FES in four experimental sessions separated by two weeks. In each session, either active tDCS + sham PNS, active PNS + sham tDCS,active tDCS + active PNS or sham tDCS + sham PNS will be applied. PNS will be applied for 2 hours and tDCS will be applied in the last 20 minutes before completion of PNS. The order of the sessions will be randomized across patients. Before the first session, patients will be familiarized with the FES device.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Combined Brain and Peripheral Nerve Stimulation to Enhance Beneficial Effects of Functional Electrical Stimulation on Hand Motor Function After Stroke
Study Start Date : July 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: Active tDCS and active PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
Other: Active tDCS
Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).

Other: Active PNS
Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.

Active tDCS and sham PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
Other: Active tDCS
Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).

Other: Sham PNS
No current will be delivered to the radial, ulnar and median nerves.

Sham tDCS and active PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
Other: Active PNS
Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.

Other: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.

Sham Comparator: Sham tDCS and sham PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
Other: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.

Other: Sham PNS
No current will be delivered to the radial, ulnar and median nerves.




Primary Outcome Measures :
  1. Active Range of Motion of Wrist Extension in the Paretic Side [ Time Frame: Pre- and post-intervention on each intervention day ]
    In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age, 18 years or older;
  • First-ever, ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
  • Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function;
  • Ability to provide written Informed Consent (patient or legal representative);
  • Ability to comply with the schedule of interventions and evaluations in the protocol.

Exclusion Criteria:

  • Lack of ability to voluntarily activate any active range of wrist extension;
  • Anesthesia of the paretic hand;
  • Stroke lesions affecting entirely the hand knob area of the motor cortex120;
  • Stroke lesions affecting the cerebellum or the brain stem;
  • Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
  • Active joint deformity;
  • Uncontrolled medical problems such as end-stage cancer or renal disease;
  • Pregnancy;
  • Seizures;
  • Pacemakers;
  • Other neurological disorders such as Parkinson's disease;
  • Psychiatric illness including severe depression;
  • Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent. A score in the Minimental State Examination lower than 23/30 points will be used for patients with higher than 1 year of education, and a score lower than 19/30 will be used for patients with 1 year of education or less.

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): NCT01907737


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação Faculdade de Medicina
Investigators
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Principal Investigator: Adriana Conforto, MD PhD Instituto do Coracao

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Responsible Party: Adriana Bastos Conforto, Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01907737     History of Changes
Other Study ID Numbers: P0546/11
First Posted: July 25, 2013    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases