---
title: Brain stimulation reduces movement fluctuations
nct_id: NCT01682668
phase: NA
status: RECRUITING
sponsor: Institut National de la Santé Et de la Recherche Médicale, France
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT01682668"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01682668"
last_fetched: "2026-05-10T14:03:23.416Z"
source: "Parkinson's Pathways (curated)"
---
# Brain stimulation reduces movement fluctuations

**Goal (in five words):** Brain stimulation reduces movement fluctuations

**Official Title:** Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.

**Trial ID:** [NCT01682668](https://clinicaltrials.gov/study/NCT01682668)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Institut National de la Santé Et de la Recherche Médicale, France
- **Target Enrollment:** 180 participants
- **Start Date:** 2013-02
- **Completion Date:** 2025-05
- **Conditions:** Parkinson's Disease
- **Interventions:** Bilateral subthalamic stimulation
- **Intervention Types:** PROCEDURE

## Summary For Families

Goal: Learn how the subthalamic nucleus drives akinesia and other movement problems in Parkinson's, and whether targeting it can reduce motor fluctuations, dyskinesias, and gait or balance issues. Approach: Bilateral deep brain stimulation of the subthalamic nucleus uses implanted electrodes to send continuous electrical pulses that normalize abnormal basal ganglia firing, improving movement and often allowing lower levodopa doses. Eligibility: Adults 18 to 70 with idiopathic Parkinson's are sought, including surgical candidates with motor complications and excellent levodopa responsiveness (greater than 50% improvement on testing), plus separate groups of non-operated and already-operated patients; people with dementia, unstable psychiatric illness, MRI contraindications, or other surgical risks are excluded.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion criteria for patients who will be operated

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
2. Age between 18 and 70;
3. Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
4. Other medical conditions that are stable or do not interfere with the procedure proposed;
5. Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
6. Brain MRI without abnormality
7. Normality of biological examinations
8. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
9. Patient with social health insurance

Criteria for non-inclusion of Parkinsonian patients who will be operated

1. Contraindication to examinations necessary for inclusion
2. Evolutionary psychiatric pathology;
3. Dementia(MMS\<24/30);
4. Patients with a medical condition that makes surgery dangerous neuro-surgical;
5. Bleeding-promoting diseases and laboratory test abnormalities clotting;
6. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
7. Taking drugs interfering with coagulation for 1 month before intervention.
8. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty

Selection criteria for non-operated patients

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
2. Age between 18 and 70;
3. Other medical conditions that are stable or do not interfere with the proposed protocol;
4. Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment
5. Brain MRI without notable abnormality
6. Normality of biological examinations
7. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
8. Patient with social health insurance

Criteria for non-inclusion of non-operated patients

1. Contraindication to examinations necessary for inclusion
2. Progressive psychiatric pathology;
3. Dementia (MMS\<24/30);
4. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
5. Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty

Inclusion criteria for group 3 patients (already operated)

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
2. Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year
3. Age between 18 and 70;
4. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
5. Patient with social health insurance

Criteria for non-inclusion of Parkinsonian patients (already operated)

1. Contraindication to examinations necessary for inclusion
2. Evolutionary psychiatric pathology;
3. Dementia(MMS\<24/30);
4. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty

Inclusion criteria for healthy subjects

1. Age between 18 and 70 years old
2. Normal neurological examination
3. Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)
4. Patient with social health insurance

Criteria for non-inclusion of healthy subjects

1. Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom
2. Existence of neurological, orthopedic or psychiatric history
3. Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia).
```

## Locations (2)

- CIC-GHPS, Paris, France _(48.8534, 2.3488)_
  - Marie-Laure WELTER, PH — (CONTACT) — 0142162461 — marielaure.welter@icm-institute.org
- Groupe Hospitalier Pitie-Salpêtrière, Paris, France _(48.8534, 2.3488)_
  - Marie-Laure Welter, MD, PhD — (CONTACT) — marie-laure.welter@psl.aphp.fr

## Central Contacts

- Marie-Laure Welter, MD, PhD — (CONTACT) — marielaure.welter@icm-institute.org
- Carine Karachi, MD, PhD — (CONTACT) — carine.karachi@gmail.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT01682668*  
*HTML version: https://parkinsonspathways.com/trial/NCT01682668*  
*Source data: https://clinicaltrials.gov/study/NCT01682668*