Efficacy of rTMS on Pain Following Stroke.

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03354052
• Other study ID #: Stroke_rTMS_Pain
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2022
• Source: University Hospital of Ferrara
• Contact: Sofia Straudi, MD, PhD
• Phone: 0532238720
• Email: s.straudi[@]ospfe.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)	Core outcome measure of pain intensity in pain treatments' clinical trials	Change measures (weeks: 0,2,6)
Secondary	Neuropathic Pain Symptom Inventory (NPSI)	A self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain.	Change measures (weeks: 0,2,6)
Secondary	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)
Secondary	Beck Depression Inventory II (BDI-II)	Assessment of severity of common depressive symptoms.	Change measures (weeks: 0,2,6)
Secondary	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)
Secondary	Fugl-Meyer Assessment - Upper Extremity (FM-UE)	Assessment of upper limb function.	Change measures (weeks: 0,2,6)
Secondary	Barthel Index (BI)	Scale that measures disability or dependence in activities of daily living in stroke patients.	Change measures (weeks: 0,2,6)
Secondary	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)
Secondary	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)
Secondary	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)