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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335668
• Other study ID #: 2020-02640
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Andreas Nowacki, MD
• Phone: +41316322409
• Email: andreas.nowacki[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria patients:

• 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

Exclusion Criteria patients:

• 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

Inclusion Criteria for healthy volunteers

• Informed consent as documented by signature

• Age: =18 years and = 75 years

Exclusion criteria for healthy volunteers

• Pregnancy and breastfeeding

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Switzerland	Dep. of Neurosurgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cerebral connectivity patterns	Correlation between cerebral connectivity patterns at rest during pain-processing tasks based on functional MRI	Day 30 after inclusion