Parkinson DiseaseCAMPTOSTIMNCT06291051
Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia
A study testing Electrical spinal cord stimulation in people with Parkinson Disease, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Electrical spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Aug 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Chu Amiens
Amiens, 80054
Melissa Tir, Dr, 03 22 08 83 73, tir.melissa@chu-amiens.fr
Mélissa Tir, Dr
- Recruiting
CHU CAEN
Caen, 14033
Claire Thiriez, Dr, 02-31-06-52-94, Thiriez-c@chu-caen.fr
Claire Thiriez, Dr
- Recruiting
Chu Lille
Lille, 59037
Luc Defebvre, Pr, 0320446072, luc.defebvre@chu-lille.fr
Luc Defebvre, Pr
- Recruiting
Chu Rouen
Rouen, 76031
Stéphane Derrey, Pr, 02 32 88 80 42, Stephane.Derrey@chu-rouen.fr
Stéphane Derrey, Pr
About this study
Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.
Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD.
- Conditions
- Parkinson Disease
- Being tested
- Electrical spinal cord stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical spinal cord stimulationDevice
electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia
| Study group | Role | What they receive |
|---|---|---|
| Electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia | Experimental | Not described Receives: Device: Electrical spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia
The presence of intraoperative or postoperative adverse events, including in particular short-term postoperative complications but also any adverse event observed until the end of study visit (V7) at 10 - 11 months post-operative operative approximately.
Measured: 11 months post-operative operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Aug 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291051
- Sponsor's protocol ID
- 2021/0382/HP
- Acronym
- CAMPTOSTIM
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia
- ClinicalTrials.gov ID
- NCT06291051
- Acronym / sponsor ID
- CAMPTOSTIM / 2021/0382/HP
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.
Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia | Experimental | Device: Electrical spinal cord stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (20 listed)
- Atypical parkinsonian syndrome
- Contraindication to surgery and anesthetic products
- Uncontrolled diabetes
- Systemic or local infection
- Major cognitive disorders: MOCA < 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical spinal cord stimulationelectrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia | Device | Electrical spinal cord stimulation in Parkinson's patients presenting with painful camptocormia |
Primary outcome
Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia
Time frame: 11 months post-operative operative
The presence of intraoperative or postoperative adverse events, including in particular short-term postoperative complications but also any adverse event observed until the end of study visit (V7) at 10 - 11 months post-operative operative approximately.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical spinal cord stimulation in people with Parkinson Disease, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Derrey, Pr (02 32 88 80 42, Stephane.Derrey@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia (time frame: 11 months post-operative operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.