Efficacy of rTMS on Pain Following Stroke.
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Real-rTMS + Gloreha device
Sham-rTMS + Gloreha device
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Pain, rTMS, Rehabilitation
Eligibility 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
Sites / Locations
- Ferrara University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Real-rTMS + Gloreha device
Sham-rTMS + Gloreha device
Arm Description
Outcomes
Primary Outcome Measures
Numeric Rating Scale (NRS)
Core outcome measure of pain intensity in pain treatments' clinical trials
Secondary Outcome Measures
Neuropathic Pain Symptom Inventory (NPSI)
A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.
Short Form McGill Pain Questionnaire (SF-MPQ)
Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Beck Depression Inventory II (BDI-II)
Assessment of severity of common depressive symptoms.
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)
Assessment of sensory function following brain injury.
Fugl-Meyer Assessment - Upper Extremity (FM-UE)
Assessment of upper limb function.
Barthel Index (BI)
Scale that measures disability or dependence in activities of daily living in stroke patients.
Pressure Pain Threshold (PPT)
PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Electroencephalography (EEG) recordings
EEG data will be recorded to test presence of particular brain activity in condition of pain.
Motor cortex excitability (single pulse TMS)
Single pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).
Full Information
NCT ID
NCT03354052
First Posted
November 21, 2017
Last Updated
May 24, 2022
Sponsor
University Hospital of Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT03354052
Brief Title
Efficacy of rTMS on Pain Following Stroke.
Official Title
Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Pain, rTMS, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real-rTMS + Gloreha device
Arm Type
Experimental
Arm Title
Sham-rTMS + Gloreha device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Real-rTMS + Gloreha device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham-rTMS + Gloreha device
Intervention Description
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 Measure Information:
Title
Numeric Rating Scale (NRS)
Description
Core outcome measure of pain intensity in pain treatments' clinical trials
Time Frame
Change measures (weeks: 0,2,6)
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.
Time Frame
Change measures (weeks: 0,2,6)
Title
Short Form McGill Pain Questionnaire (SF-MPQ)
Description
Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Time Frame
Change measures (weeks: 0,2,6)
Title
Beck Depression Inventory II (BDI-II)
Description
Assessment of severity of common depressive symptoms.
Time Frame
Change measures (weeks: 0,2,6)
Title
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)
Description
Assessment of sensory function following brain injury.
Time Frame
Change measures (weeks: 0,2,6)
Title
Fugl-Meyer Assessment - Upper Extremity (FM-UE)
Description
Assessment of upper limb function.
Time Frame
Change measures (weeks: 0,2,6)
Title
Barthel Index (BI)
Description
Scale that measures disability or dependence in activities of daily living in stroke patients.
Time Frame
Change measures (weeks: 0,2,6)
Title
Pressure Pain Threshold (PPT)
Description
PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Time Frame
Change measures (weeks: 0,2,6)
Title
Electroencephalography (EEG) recordings
Description
EEG data will be recorded to test presence of particular brain activity in condition of pain.
Time Frame
Change measures (weeks: 0,2,6)
Title
Motor cortex excitability (single pulse TMS)
Description
Single pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).
Time Frame
Change measures (weeks: 0,2,6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD, PhD
Phone
0532238720
Email
s.straudi@ospfe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT
Phone
+390532238720
Email
brnndr3@unife.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT, MsC
First Name & Middle Initial & Last Name & Degree
Giulia Zani, PsyD
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD
First Name & Middle Initial & Last Name & Degree
Sergio Buja, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of rTMS on Pain Following Stroke.
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