Clinical trial NCT03354052: Efficacy of rTMS on Pain Following Stroke.
Official title: Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Pain
rTMS
Rehabilitation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Change measures (weeks: 0,2,6)
Secondary outcomes:
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Change measures (weeks: 0,2,6)
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Change measures (weeks: 0,2,6)
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Change measures (weeks: 0,2,6)
measure: Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)
timeFrame: Change measures (weeks: 0,2,6)
measure: Fugl-Meyer Assessment - Upper Extremity (FM-UE)
timeFrame: Change measures (weeks: 0,2,6)
measure: Barthel Index (BI)
timeFrame: Change measures (weeks: 0,2,6)
measure: Pressure Pain Threshold (PPT)
timeFrame: Change measures (weeks: 0,2,6)
measure: Electroencephalography (EEG) recordings
timeFrame: Change measures (weeks: 0,2,6)
measure: Motor cortex excitability (single pulse TMS)
timeFrame: Change measures (weeks: 0,2,6)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD, PhD
role: STUDY_DIRECTOR
References: