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Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients

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ClinicalTrials.gov Identifier: NCT02393651
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Rick van der Vliet, Erasmus Medical Center

Brief Summary:

Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.

Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.

Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.


Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Study Start Date : March 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Placebo Comparator: Sham
Motor training of the affected upper extremity combined with sham tDCS.
Device: tDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.

Experimental: tDCS
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Device: tDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.




Primary Outcome Measures :
  1. Change from baseline in Upper Extremity Fugl Meyer Assessment [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks ]

Secondary Outcome Measures :
  1. ARAT [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks ]
  2. Hand grip strength [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks ]
  3. 10-meter walk test [ Time Frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks ]
  4. EuroQol-5D [ Time Frame: 12 weeks ]
  5. Barthel Index [ Time Frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks ]
  6. HADS [ Time Frame: Baseline; 4 weeks and 12 weeks ]
  7. MoCA [ Time Frame: Baseline; 4 weeks and 12 weeks ]
  8. Wong-Baker FACES Pain Rating Scale [ Time Frame: Every stimulation session ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subacute stroke (within 1-4 weeks post stroke)
  • Acute hemiparesis (Fugl-Meyer Stage < IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
  • Aged 18-79

Exclusion Criteria:

  • Absence of voluntary movement (Fugl-Meyer Stage < III)
  • Head injury or the presence of intracranial metal or intracranial lesions
  • History of cranial irradiation
  • History of epilepsy
  • Presence of a pacemaker
  • Taking anticonvulsant or neuroleptic medication
  • Substance abuse
  • Inability to understand instructions

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): NCT02393651


Contacts
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Contact: Rick van der Vliet, MSc +31622857402 r.vandervliet@erasmusmc.nl

Locations
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Netherlands
Rijndam Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015LJ
Contact: Gerard Ribbers, PhD MD    +31102412411    gribbers@rijndam.nl   
Sponsors and Collaborators
Erasmus Medical Center

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Responsible Party: Rick van der Vliet, MSc, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02393651     History of Changes
Other Study ID Numbers: MEC-2014-503
NL49887.078.14 ( Other Identifier: CCMO )
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms