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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05335668
Collaborator
(none)
88
1
3
25.5
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Clinical Testing
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Brain Circuitry Changes in Central Poststroke Pain: a Clinical and Neuroimaging Study
Actual Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with central poststroke pain

Patients with central poststroke pain

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)

Experimental: Patients without central poststroke pain

Patients without central poststroke pain

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)

Active Comparator: healthy controls

healthy volunteers

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)

Outcome Measures

Primary Outcome Measures

  1. Correlation between cerebral connectivity patterns [Day 30 after inclusion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dep. of Neurosurgery, Bern University Hospital Bern Switzerland 3000

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Claudio Pollo, MD, Inselspital Bern, Department of Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT05335668
Other Study ID Numbers:
  • 2020-02640
First Posted:
Apr 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2022