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NCT Number: NCT00940914

Dopaminergic Loss and Pain in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ioflupane 123I (DATSCAN®)

Drug

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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).

  2. Short French version of McGill pain questionnaire (MPQ).

    Time frame: Evaluation will be done within three hours before image acquisition (SPECT).

  3. 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).

  4. DN4 scale

    Time frame: Evaluation will be done within three hours before image acquisition (SPECT).

  5. Brief Inventory Pain

    Time frame: Evaluation will be done within three hours before image acquisition (SPECT).

  6. Hospital Anxiety and Depression (HAD) scale

    Time frame: Evaluation will be done within three hours before image acquisition (SPECT).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2009
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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