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Efficacy of rTMS on Pain Following 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: NCT03354052
Recruitment Status : Unknown
Verified January 2018 by Sofia Straudi, University Hospital of Ferrara.
Recruitment status was:  Recruiting
First Posted : November 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, University Hospital of Ferrara

Brief Summary:
Pain is a common symptom experienced by people following stroke and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This is a pilot randomized control trial to test the effects of rTMS in stroke-related pain rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in daily livings activities. Furthermore, we will explore the effects on pressure pain threshold, cortical excitability and EEG recording.

Condition or disease Intervention/treatment Phase
Stroke Device: Real-rTMS + Gloreha device Device: Sham-rTMS + Gloreha device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: Real-rTMS + Gloreha device Device: Real-rTMS + Gloreha device
The real rTMS will be delivered using a 8-shaped coil placed over the primary motor cortex (M1). The resting motor threshold (RMT) will be assessed at the place of the first dorsal interosseous (FDI) contralateral to the stimulated cortex. RMT of the FDI will be determined as the lowest strength of TMS needed to elicit 5 or more electromyographic responses ≥50 μV within 10 trials. Stimulation will be applied with frequency 10 Hz and intensity of 90% of RMT. Every session will last 15 minutes and includes 3000 pulses (30 trains of 10 seconds, following intertrain interval of 20 seconds). Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.

Active Comparator: Sham-rTMS + Gloreha device Device: Sham-rTMS + Gloreha device
The sham rTMS will be delivered using a sham stimulator. All procedures will be performed as for the real treatment. Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Core outcome measure of pain intensity in pain treatments' clinical trials


Secondary Outcome Measures :
  1. Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Change measures (weeks: 0,2,6) ]
    A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.

  2. Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Assessment of sensory and affective dimensions of typical whole-body pain intensity.

  3. Beck Depression Inventory II (BDI-II) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Assessment of severity of common depressive symptoms.

  4. Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Assessment of sensory function following brain injury.

  5. Fugl-Meyer Assessment - Upper Extremity (FM-UE) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Assessment of upper limb function.

  6. Barthel Index (BI) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Scale that measures disability or dependence in activities of daily living in stroke patients.

  7. Pressure Pain Threshold (PPT) [ Time Frame: Change measures (weeks: 0,2,6) ]
    PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.

  8. Electroencephalography (EEG) recordings [ Time Frame: Change measures (weeks: 0,2,6) ]
    EEG data will be recorded to test presence of particular brain activity in condition of pain.

  9. Motor cortex excitability (single pulse TMS) [ Time Frame: Change measures (weeks: 0,2,6) ]
    Single pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of first stroke verified by brain imaging < 6 months
  • pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain and a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception

Exclusion Criteria:

  • medical conditions likely to interfere with the ability to safely complete the study protocol
  • cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30
  • intracranial metal implants
  • history of seizures or epilepsy
  • severe cardiopulmonary, renal, and hepatic diseases
  • pregnancy

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): NCT03354052


Contacts
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Contact: Sofia Straudi, MD, PhD 0532238720 s.straudi@ospfe.it

Locations
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Italy
Ferrara University Hospital Recruiting
Ferrara, Italy, 44124
Contact: Andrea Baroni, PT    +390532238720    brnndr3@unife.it   
Sub-Investigator: Sofia Straudi, MD, PhD         
Sub-Investigator: Andrea Baroni, PT, MsC         
Sub-Investigator: Giulia Zani, PsyD         
Principal Investigator: Nino Basaglia, MD         
Sub-Investigator: Sergio Buja, MD         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Study Director: Sofia Straudi, MD, PhD Ferrara Rehabilitation Hospital
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Responsible Party: Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03354052    
Other Study ID Numbers: Stroke_rTMS_Pain
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Straudi, University Hospital of Ferrara:
Pain
rTMS
Rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases