Efficacy of rTMS on Pain Following Stroke.

NCT03354052 | Unknown

• 1 other identifier: Stroke_rTMS_Pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Pain; rTMS; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Core outcome measure of pain intensity in pain treatments' clinical trials

  Change measures (weeks: 0,2,6)

Secondary Outcomes (9)

• Neuropathic Pain Symptom Inventory (NPSI)

  Change measures (weeks: 0,2,6)

• Short Form McGill Pain Questionnaire (SF-MPQ)

  Change measures (weeks: 0,2,6)

• Beck Depression Inventory II (BDI-II)

  Change measures (weeks: 0,2,6)

• Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)

  Change measures (weeks: 0,2,6)

• Fugl-Meyer Assessment - Upper Extremity (FM-UE)

  Change measures (weeks: 0,2,6)

Study Arms (2)

Real-rTMS + Gloreha device

EXPERIMENTAL

Device: Real-rTMS + Gloreha device

Sham-rTMS + Gloreha device

ACTIVE COMPARATOR

Device: Sham-rTMS + Gloreha device

Interventions

Real-rTMS + Gloreha device 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.

Real-rTMS + Gloreha device

Sham-rTMS + Gloreha device 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.

Sham-rTMS + Gloreha device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofia Straudi, MD, PhD

  Ferrara Rehabilitation Hospital

  STUDY DIRECTOR

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

0532238720; s.straudi@ospfe.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)