Dopaminergic Loss and Pain in Parkinson's Disease

July 28, 2020 updated by: University Hospital, Toulouse

Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: pain disorders
patients with Parkinson's disease presenting pain disorders
Drug: ioflupane 123I (DATSCAN®)
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Other Names:
  • - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane
  • - FP-CIT
OTHER: without pain disorders
patients with Parkinson's disease without pain disorders
Drug: ioflupane 123I (DATSCAN®)
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Other Names:
  • - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane
  • - FP-CIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
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.
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Evaluation will be done within three hours before image acquisition (SPECT).
Short French version of McGill pain questionnaire (MPQ).
Time Frame: Evaluation will be done within three hours before image acquisition (SPECT).
Evaluation will be done within three hours before image acquisition (SPECT).
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).
Evaluation will be done within three hours before image acquisition (SPECT).
DN4 scale
Time Frame: Evaluation will be done within three hours before image acquisition (SPECT).
Evaluation will be done within three hours before image acquisition (SPECT).
Brief Inventory Pain
Time Frame: Evaluation will be done within three hours before image acquisition (SPECT).
Evaluation will be done within three hours before image acquisition (SPECT).
Hospital Anxiety and Depression (HAD) scale
Time Frame: Evaluation will be done within three hours before image acquisition (SPECT).
Evaluation will be done within three hours before image acquisition (SPECT).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 16, 2009

First Posted (ESTIMATE)

July 17, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0730302
  • AOL 2007 (Other Identifier: AOL 2007)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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