Brain Circuitry Changes in Central Poststroke Pain: a Clinical and Neuroimaging Study

NCT05335668 | Recruiting

• 1 other identifier: 2020-02640
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Central poststroke pain (CPP) is estimated to affect up to 10% of stroke patients and is one of the most difficult-to-treat conditions with a detrimental effect on patient's quality of life. So far, no drug has proven efficient to alleviate CPP and neuromodulation approaches including Deep Brain Stimulation (DBS) and motor-cortex stimulation have yielded mixed results with only a few patients experiencing long-term pain relief. To date, little is known about the pathophysiology of CPP. There is at present little evidence for a clear association between the specific location of lesions, clinical manifestation and phenomenology of pain as well as treatment response of CPP patients. Furthermore, the time delay between stroke occurrence and CPP occurrence is highly variable and the fact, that it is not immediate in the great majority of patients suggests that other factors contribute to the development of CPP. These factors have not been identified yet.

Conditions

CPP; Pain

Outcome Measures

Primary Outcomes (1)

• Correlation between cerebral connectivity patterns

  Correlation between cerebral connectivity patterns at rest during pain-processing tasks based on functional MRI

  Day 30 after inclusion

Study Arms (3)

Patients with central poststroke pain

EXPERIMENTAL

Patients with central poststroke pain

Procedure: Clinical Testing

Patients without central poststroke pain

EXPERIMENTAL

Patients without central poststroke pain

Procedure: Clinical Testing

healthy controls

ACTIVE COMPARATOR

healthy volunteers

Procedure: Clinical Testing

Interventions

Clinical Testing PROCEDURE

Clinical testing for neurological deficits based on National Institute of Health Stroke Scale (NIHSS), objective sensory testing and pain assessment by quantitative sensory testing (QST) and quantitative pain drawings, 7T magnetic resonance imaging (MRI)

Patients with central poststroke pain; Patients without central poststroke pain; healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a haemorrhagic or ischemic stroke affecting the somatosensory system as defined by both CT or MRI and clinical criteria
• Patient age between 18-75 years
• Signed written informed consent

You may not qualify if:

• Secondary stroke due to a cerebral vascular malformation or tumor
• Patients with aphasic syndromes and impaired verbal communication, complete sensory-motor hemi-neglect and restrictions of the ability to report on their pain and cooperate during sensory testing
• Patients with severe stroke NIHSS \> 14 and or Modified Rankin Scale (MRS) \> 3
• History of severe myelopathy or polyneuropathy with clinical sensory deficits and history of neuropathic pain
• Widespread stroke size due to internal carotid artery-occlusion or more than one main territory (anterior, middle or posterior cerebral artery)
• Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)
• In case of women \< 45 years of age: pregnancy
• Informed consent as documented by signature
• Age: ≥18 years and ≤ 75 years
• Pregnancy and breastfeeding
• Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3000, Switzerland

RECRUITING

Related Publications (4)

• Bowsher D. Central pain: clinical and physiological characteristics. J Neurol Neurosurg Psychiatry. 1996 Jul;61(1):62-9. doi: 10.1136/jnnp.61.1.62.

  PMID: 8676164 BACKGROUND

• Bowsher D, Leijon G, Thuomas KA. Central poststroke pain: correlation of MRI with clinical pain characteristics and sensory abnormalities. Neurology. 1998 Nov;51(5):1352-8. doi: 10.1212/wnl.51.5.1352.

  PMID: 9818859 BACKGROUND

• Karahanoglu FI, Van De Ville D. Transient brain activity disentangles fMRI resting-state dynamics in terms of spatially and temporally overlapping networks. Nat Commun. 2015 Jul 16;6:7751. doi: 10.1038/ncomms8751.

  PMID: 26178017 BACKGROUND

• Preti MG, Bolton TA, Van De Ville D. The dynamic functional connectome: State-of-the-art and perspectives. Neuroimage. 2017 Oct 15;160:41-54. doi: 10.1016/j.neuroimage.2016.12.061. Epub 2016 Dec 26.

  PMID: 28034766 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Claudio Pollo, MD

  Inselspital Bern, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Nowacki, MD

CONTACT

+41316322409; andreas.nowacki@insel.ch

Claudio Pollo, MD

CONTACT

28034766; claudio.pollo@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: July 18, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)