Brain pump delivers dopamine directly to fight Parkinson's fluctuations
NCT ID NCT04332276
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new approach for people with advanced Parkinson's disease who have severe motor fluctuations despite optimized oral medication. A pump placed in the abdomen delivered a special form of dopamine (A-dopamine) directly into the brain's fluid spaces, aiming to provide steady symptom control. Only 12 participants were enrolled, and the study compared this brain pump to optimized oral treatment over two one-month periods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A-dopamine (dopamine stored in anaerobia, delivered into brain ventricles)
- What this could lead to
- If it works, this could offer a new way to control severe motor ups and downs in Parkinson's with fewer daily pills.
- What could go wrong
- This is a very early, small study (12 people) testing an invasive brain procedure. It may not prove safe or effective, and risks include infection or pump problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
12 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
May 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Parkinson\'s disease at the stage of L-dopa-induced severe motor and non-motor complications * Men or women over 18 years old * Parkinson\'s disease according to MDS criteria * Severe motor complications including motor fluctuations with at least 2 hours of Off and 1 hour of dyskinesias uncontrolled by optimized oral drug therapy, i.e. with at least 5 doses of L-dopa and the addition or trial of a dopaminergic agonist (if tolerated) per os or by apomorphine pump * The patient meets the criteria for a second-line invasive treatment such as deep brain stimulation (subthalamic or medial pallidum) or intrajejunal administration of levodopa gel (Duodopa®). * Patients with a contraindication or who prefer this invasive therapeutic alternative to the other two existing and validated therapies (subthalamic stimulation or Duodopa®) because of its advantages: lower theoretical risk of intracerebroventricular delivery compared to subthalamic stimulation and better ergonomics than Duodopa®, but with the disadvantage of an as yet unproven benefit. * Social security * Able to provide free and informed consent to participate in research * Patient willing to comply with all study procedures and duration * Patient not planning to change lifestyle (nutritionally, physically or socially) during study participation Exclusion Criteria: * Over 75 years of age * Subjects not receiving at least 5 doses per day of oral dopaminergic therapy * Subject without a prior trial of an apomorphine pump (of lower risk); apomorphine pump treatment being a failure or a contraindication or refused by the patient * Psychiatric history using the semi-structured psychiatric interview with DSM IV MINI: decompensated bipolar illness, psychotic state, current severe depression. Dysthymia and an isolated history of depression are not exclusion criteria. * Patient with parkinsonian dementia (DSM IV and MDS criteria and MOCA score \< or equal to 22) * Isolated patient, defined as the absence of a caregiver present at least 3 hours/day in the patient\'s home. * History of a fall in the last 6 months and/or a score \>1 on items 2.12 (Walking and balance) and/or 3.12 (Postural stability) of the MDS-UPDRS scale * Presence of another serious pathology threatening short- or medium-term vital prognosis, malnourished or cachectic patient. * Hemostasis disorders * Cardiac rhythm disorders and/or heart failure not controlled by treatment * Uncontrolled blood pressure release * Breastfeeding and pregnancy * Women of childbearing age without effective contraception * Contraindication to general anaesthesia * Taking treatments containing guanethidine or related compounds or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone) * Neurosurgical contraindication (severe cerebral atrophy, brain tumor, infarction or other cerebral pathology, CSF flow disorder) * Contraindication to abdominal placement of a subcutaneous pump and catheter that impairs healing and transcutaneous filling (e.g. major obesity, skin pathology, etc.). * Contraindication to MRI (pacemaker, claustrophobia, etc.) and/or intolerance to gadolinium * Active infectious pathology (including Covid-19) * Immunologically deficient pathology likely to promote superinfection of equipment * Patients under guardianship or trusteeship * Patient already participating in another therapeutic trial using an investigational drug or in an exclusion period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Roger Salengro, CHU Lille
Lille, 59037, France
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