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Combined Brain and Peripheral Nerve Stimulation for Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Adriana Bastos Conforto, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01907737
First received: July 14, 2013
Last updated: September 10, 2013
Last verified: September 2013

July 14, 2013
September 10, 2013
July 2013
July 2015   (final data collection date for primary outcome measure)
  • Active range of motion of wrist extension in the paretic side [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    In this cross-over study, the primary outcome will be measured immediately before and after each session of treatment. In each session, one of the four possible interventions will be administered.The interval between each of the four experimental sessions will be 2 weeks.
  • Active range of motion of wrist extension in the paretic side [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Active range of motion of wrist extension in the paretic side [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Active range of motion of wrist extension in the paretic side [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01907737 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Brain and Peripheral Nerve Stimulation for Stroke
Combined Brain and Peripheral Nerve Stimulation to Enhance Beneficial Effects of Functional Electrical Stimulation on Hand Motor Function After Stroke

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Stroke
  • Other: Active tDCS and active PNS

    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).

    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 Names:
    • Transcranial direct current stimulation
    • Peripheral nerve stimulation
  • Other: Active tDCS and sham PNS
    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). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
  • Other: Sham tDCS and active PNS
    In sham tDCS, no current will be delivered through the tDCS device. 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 and sham PNS
    No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves.
  • 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
    Intervention: Other: Active tDCS and active PNS
  • 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
    Intervention: Other: Active tDCS and sham PNS
  • 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
    Intervention: Other: Sham tDCS and active PNS
  • 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
    Intervention: Other: Sham tDCS and sham PNS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
December 2015
July 2015   (final data collection date for primary outcome measure)

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 upperlimb 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.
Both
18 Years and older
No
Contact: Inara Siqueira 551126617955 nahsiqueira@gmail.com
Brazil
 
NCT01907737
P0546/11
Yes
Adriana Bastos Conforto, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Fundação Faculdade de Medicina
Not Provided
University of Sao Paulo General Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP