Efficacy of rTMS on Pain Following Stroke.

Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Real-rTMS + Gloreha device; Device: Sham-rTMS + Gloreha device

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Straudi, MD, PhD; Phone Number: 0532238720; Email: s.straudi@ospfe.it

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Recruiting
    • Ferrara University Hospital
    • Contact: Andrea Baroni, PT; Phone Number: +390532238720; Email: brnndr3@unife.it
    • Sub-Investigator: Sofia Straudi, MD, PhD
    • Sub-Investigator: Sergio Buja, MD
    • Sub-Investigator: Andrea Baroni, PT, MsC
    • Sub-Investigator: Giulia Zani, PsyD
    • Principal Investigator: Nino Basaglia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS)	Core outcome measure of pain intensity in pain treatments' clinical trials	Change measures (weeks: 0,2,6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain Symptom Inventory (NPSI)	A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.	Change measures (weeks: 0,2,6)
Short Form McGill Pain Questionnaire (SF-MPQ)	Assessment of sensory and affective dimensions of typical whole-body pain intensity.	Change measures (weeks: 0,2,6)
Beck Depression Inventory II (BDI-II)	Assessment of severity of common depressive symptoms.	Change measures (weeks: 0,2,6)
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)	Assessment of sensory function following brain injury.	Change measures (weeks: 0,2,6)
Fugl-Meyer Assessment - Upper Extremity (FM-UE)	Assessment of upper limb function.	Change measures (weeks: 0,2,6)
Barthel Index (BI)	Scale that measures disability or dependence in activities of daily living in stroke patients.	Change measures (weeks: 0,2,6)
Pressure Pain Threshold (PPT)	PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.	Change measures (weeks: 0,2,6)
Electroencephalography (EEG) recordings	EEG data will be recorded to test presence of particular brain activity in condition of pain.	Change measures (weeks: 0,2,6)
Motor cortex excitability (single pulse TMS)	Single pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).	Change measures (weeks: 0,2,6)

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Study Director: Sofia Straudi, MD, PhD, Ferrara Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Pain; rTMS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Stroke_rTMS_Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No