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Efficacy of rTMS on Pain Following Stroke.

U

University Hospital of Ferrara

Status

Unknown

Conditions

Stroke

Treatments

Device: Sham-rTMS + Gloreha device
Device: Real-rTMS + Gloreha device

Study type

Interventional

Funder types

Other

Identifiers

NCT03354052
Stroke_rTMS_Pain

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Real-rTMS + Gloreha device
Experimental group
Treatment:
Device: Real-rTMS + Gloreha device
Sham-rTMS + Gloreha device
Active Comparator group
Treatment:
Device: Sham-rTMS + Gloreha device

Trial contacts and locations

1

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Central trial contact

Sofia Straudi, MD, PhD

Data sourced from clinicaltrials.gov

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