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
  Purpose

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 Intervention
Stroke
Other: Active tDCS and active PNS
Other: Active tDCS and sham PNS
Other: Sham tDCS and active PNS
Other: Sham tDCS and sham PNS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Combined Brain and Peripheral Nerve Stimulation to Enhance Beneficial Effects of Functional Electrical Stimulation on Hand Motor Function After Stroke

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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.
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
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.
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
Other: Sham tDCS and sham PNS
No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907737

Contacts
Contact: Inara Siqueira 551126617955 nahsiqueira@gmail.com

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Inara Siqueira       nahsiqueira@gmail.com   
Contact: Adriana Conforto       adriana.conforto@gmail.com   
Principal Investigator: Adriana B Conforto, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação Faculdade de Medicina
  More Information

No publications provided

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
Study First Received: July 14, 2013
Last Updated: September 10, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014