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

NCT ID: NCT05335668

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2025-09-30

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.

Detailed Description

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 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.

The objective of this research project is to correlate clinical aspects of CPP (pain phenomenology) with magnetic resonance image (MRI)-based findings, especially metabolic changes and functional reorganization processes captured by functional MRI and MR spectroscopy. A better understanding of the underlying pathophysiological mechanism of CPP and its involved neuronal networks are mandatory for any future therapeutic approach to treat this difficult condition. The discovery of a potential image-based biomarker could serve to help identify patients early who are at risk of developing CPP. Furthermore, the findings may help identify prognosticators of different forms of CPP treatments (e.g. biofeed-back, neuromodulation approaches, medication) in the future.

Conditions

CPP; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with central poststroke pain

Patients with central poststroke pain

Group Type: EXPERIMENTAL

Clinical Testing

Intervention Type: 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 without central poststroke pain

Patients without central poststroke pain

Group Type: EXPERIMENTAL

Clinical Testing

Intervention Type: 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)

healthy controls

healthy volunteers

Group Type: ACTIVE_COMPARATOR

Clinical Testing

Intervention Type: 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)

Interventions

Clinical Testing

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Informed consent as documented by signature
• Age: ≥18 years and ≤ 75 years

Exclusion Criteria

• 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

• Pregnancy and breastfeeding
• Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Pollo, MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital Bern, Department of Neurosurgery

Locations

Dep. of Neurosurgery, Bern University Hospital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Andreas Nowacki, MD

Role: CONTACT

andreas.nowacki@insel.ch

+41316322409

Claudio Pollo, MD

Role: CONTACT

claudio.pollo@insel.ch

28034766

Facility Contacts

Andreas Nowacki, MD

Role: primary

andreas.nowacki@insel.ch

+41 31 632 2409

Claudio Pollo, MD

Role: backup

claudio.pollo@insel.ch

+41 31 632 2409

References

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.

Reference Type: BACKGROUND

PMID: 8676164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9818859 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26178017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28034766 (View on PubMed)

Other Identifiers

2020-02640

Identifier Type: -

Identifier Source: org_study_id