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Dopaminergic Loss and Pain in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Pain

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ioflupane 123I (DATSCAN®)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, pain, dopamine transporters imaging

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992).
  • Male or Female patients, aged from 30 to 70 years.
  • Patients must benefit from the French Social security system.
  • Patients must give a written informed consent.
  • Female fertile patients must use an efficient method of contraception.

If patients suffer from chronic pain, pain must be related to Parkinson's disease.

Exclusion Criteria:

  • Patients with a syndrome other than the idiopathic Parkinson's disease.
  • Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed.
  • Patients suffering from another disease causing chronic pain.
  • Patients suffering from cancer.
  • Patients with cognitive dysfunction.
  • Patients not able to complete the scales.
  • Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception.
  • Patients not willing to participle in the trial.

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

pain disorders

without pain disorders

Arm Description

patients with Parkinson's disease presenting pain disorders

patients with Parkinson's disease without pain disorders

Outcomes

Primary Outcome Measures

Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters.
Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds.

Secondary Outcome Measures

Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale
Short French version of McGill pain questionnaire (MPQ).
Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain).
DN4 scale
Brief Inventory Pain
Hospital Anxiety and Depression (HAD) scale

Full Information

First Posted
July 16, 2009
Last Updated
July 28, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00940914
Brief Title
Dopaminergic Loss and Pain in Parkinson's Disease
Official Title
Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.
Detailed Description
Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss. The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient. Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Pain
Keywords
Parkinson's disease, pain, dopamine transporters imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pain disorders
Arm Type
Other
Arm Description
patients with Parkinson's disease presenting pain disorders
Arm Title
without pain disorders
Arm Type
Other
Arm Description
patients with Parkinson's disease without pain disorders
Intervention Type
Drug
Intervention Name(s)
ioflupane 123I (DATSCAN®)
Other Intervention Name(s)
- N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane, - FP-CIT
Intervention Description
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Primary Outcome Measure Information:
Title
Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters.
Time Frame
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Title
Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds.
Time Frame
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Secondary Outcome Measure Information:
Title
Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).
Title
Short French version of McGill pain questionnaire (MPQ).
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).
Title
Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain).
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).
Title
DN4 scale
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).
Title
Brief Inventory Pain
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).
Title
Hospital Anxiety and Depression (HAD) scale
Time Frame
Evaluation will be done within three hours before image acquisition (SPECT).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992). Male or Female patients, aged from 30 to 70 years. Patients must benefit from the French Social security system. Patients must give a written informed consent. Female fertile patients must use an efficient method of contraception. If patients suffer from chronic pain, pain must be related to Parkinson's disease. Exclusion Criteria: Patients with a syndrome other than the idiopathic Parkinson's disease. Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed. Patients suffering from another disease causing chronic pain. Patients suffering from cancer. Patients with cognitive dysfunction. Patients not able to complete the scales. Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception. Patients not willing to participle in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brefel-Courbon, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30706197
Citation
Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.
Results Reference
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Dopaminergic Loss and Pain in Parkinson's Disease

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