## Protocol Section
### Identification Module
**NCT ID:** NCT06438419

**Acronym:** MOVOSCILLCBGT

**Brief Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range

**Official Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range

#### Organization Study ID Info
**ID:** CHUBX 2023/63
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Université de Bordeaux, IMN, UMR CNRS 5293

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Bordeaux

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task.

**Detailed Description:** To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition).

### Conditions Module

**Conditions:**

- Parkinson Disease

- Hyperkinesis

- Hypokinesia

**Keywords:**

- Parkinson disease

- hypokinetic disorders

- dyskinesia

- networks

- basal ganglia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation)

**Intervention Names:**

- Other: Electrophysiological recordings

**Label:** Recruited patient

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Recruited patient

**Description:** Electrophysiological recordings will be made during a motor task in four different conditions:

1. without pharmacological treatment and without stimulation (Off condition),
2. without pharmacological treatment and during stimulation (DBS condition),
3. during pharmacological treatment and without stimulation (DOPA condition),
4. during pharmacological treatment and stimulation (DOPA+DBS condition).

**Name:** Electrophysiological recordings

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition

**Measure:** Cortico-subcortical electrophysiological coherence

**Time Frame:** At inclusion (D0)

#### Secondary Outcomes

**Description:** Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions.

**Measure:** Spectral signal power

**Time Frame:** At inclusion (D0)

**Description:** Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions

**Measure:** Effect of STN-DBS on spectral signal power

**Time Frame:** At inclusion (D0)

**Description:** Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics.

**Measure:** Correlation between semiological characteristics

**Time Frame:** At inclusion (D0)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or Female
* 18 to 75 years-old
* With idiopathic Parkinson's disease
* Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation)
* Able to perform the simple motor task
* Patients covered by a health insurance scheme
* Giving free, informed, written consent signed by the participant and the investigator.

Exclusion Criteria:

* Be incapable of giving consent personally.
* Be subject to a legal protection measure (curatorship, guardianship) or be placed under judicial protection.
* Being pregnant or breastfeeding
* Present a serious and/or decompensated somatic or psychiatric illness.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dominique.guehl@chu-bordeaux.fr

**Name:** GUEHL Dominique, Pr

**Phone:** 5 57 82 12 42

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** claire.brandet@chu-bordeaux.fr

**Name:** Claire BRANDET

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bordeaux

**Contacts:**

***Contact 1:***

- **Email:** dominique.guehl@chu-bordeaux.fr

- **Name:** Dominique Guehl, Pr

- **Role:** CONTACT

***Contact 2:***

- **Email:** claire.brandet@chu-bordeaux.fr

- **Name:** Claire BRANDET

- **Role:** CONTACT

**Country:** France

**Facility:** Bordeaux University Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000003560

- Term: Cysts

- ID: D000009369

- Term: Neoplasms

- ID: D000017520

- Term: Mucinoses

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M25603

- Name: Ganglion Cysts

- Relevance: HIGH

- As Found: Ganglion

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: HIGH

- As Found: Parkinsonism

- ID: M20582

- Name: Hypokinesia

- Relevance: HIGH

- As Found: Hypokinesia

- ID: M9999

- Name: Hyperkinesis

- Relevance: HIGH

- As Found: Hyperkinesis

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M6765

- Name: Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19781

- Name: Mucinoses

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000045888

- Term: Ganglion Cysts

- ID: D000010300

- Term: Parkinson Disease

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000018476

- Term: Hypokinesia

- ID: D000006948

- Term: Hyperkinesis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7471

- Name: Dihydroxyphenylalanine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
