Spinal zap trial aims to ease Parkinson's stoop
NCT ID NCT06291051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether electrical spinal cord stimulation is safe for people with Parkinson's disease who have a painful, bent-forward posture called camptocormia. Six participants will receive the stimulation and be monitored for side effects for about 10-11 months. The goal is to see if this approach can help with pain and posture without major risks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 validated according to UKPDSBB clinical criteria * Camptocormia defined by a total camptocormia angle (ACT) \> 30° or a greater camptocormia angle (ACS) \> 45° * Camptocormia established for less than 2 years or recently worsening for less than 1 year. * Persistent camptocormia despite optimal drug treatment at the time of inclusion * Pain associated with abnormal posture: VAS ≥ 4/10 during the last 3 months * Stable antiparkinsonian treatment for 4 weeks * Treatment with co-analgesics stable for 4 weeks * Criteria relating to regulation: * Major person * Affiliation to a social security scheme * Adult who has read and understood the information letter and signed the consent form * Women: * Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy)): * using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device IUD), male or female condoms) for 1 month before inclusion and during the study And, * presenting a negative urine pregnancy test at inclusion - Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause before the inclusion visit. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Exclusion Criteria: * Atypical parkinsonian syndrome * Contraindication to surgery and anesthetic products * Uncontrolled diabetes * Systemic or local infection * Major cognitive disorders: MOCA \< 25 * Severe psychosis associated with Parkinson's disease * Severe depressive syndrome: MADRS \> 35 * Patient with deep brain stimulation * Patient with a cardiac pacemaker * Patient currently being treated by diathermy or to be treated by diathermy * Severe substance use disorders (alcohol, drugs, medication) * Contraindication to MRI * Obstacle to the placement of a dorsal epidural electrode * Dorsal myelopathy * Severe associated scoliosis * Severe camptocormia defined by an ACT \> 80° * Severe alteration of somesthetic evoked potentials (ESP) in the lower limbs * Pregnant or parturient or breastfeeding woman or proven absence of contraception * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship * History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU CAEN
RECRUITINGCaen, 14033, France
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Chu Amiens
RECRUITINGAmiens, 80054, France
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Chu Lille
RECRUITINGLille, 59037, France
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Chu Rouen
RECRUITINGRouen, 76031, France
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Other studies related to the condition(s) this trial covers.
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