- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548801
Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease (cTDCSinPD)
Can Cerebellar Transcranial Direct Current Stimulation be Regarded as a Rational Therapeutic Option for Treating Parkinson's Disease ?
Background & Rationale:
Treatment options for Parkinson's Disease (PD) often face challenges due to the variety of clinical subtypes, differing individual responses, and disease progression. Given its portability, affordability, safety, and ease of use, cerebellar transcranial direct current stimulation (ctDCS) presents as a promising option for home-based treatment with medical telemonitoring in the near future.
Study Procedures:
Participants are invited to complete questionnaires regarding quality of life, anxiety and depression, and symptoms related to their PD.
On the first day, they will be assessed using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III for motor impairment and the Cerebellar Cognitive Affective Syndrome scale (CCAS) for cognitive impairment. Participants will then undergo an additional 8 days of at-home cTDCS stimulation. On the 10th day, they will be reassessed using the MDS-UPDRS III and CCAS. One month later, they will complete again the questionnaires regarding quality of life, anxiety, depression, and symptoms related to their PD.
Objective:
Consequently, the primary goal is to investigate the effectiveness of ctDCS in addressing both motor and non-motor symptoms of PD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1070
- Hôpital Erasme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with mild to moderate PD MDS-UPDRS part 1III or between 1 and 3 on Hoehn and Yahr score
- Patients > 18 years of agE
- Patients who have signed written informed consent
Exclusion Criteria:
- Pregnant women
- Patients ≤ 18 years of age
- Presence of intracranial metallic hardware (e.g., vascular clips, orthopedic material)
- Presence of an implanted electronic device (e.g., pacemaker, cochlear implants, deep brain stimulator)
- History of epileptic seizures
- Active or past neurological condition affecting upper limb control (e.g., stroke, degenerative disease, tumor, traumatic sequelae), or any neuromuscular (e.g., upper limb polyneuropathy, myopathy) or orthopedic condition impairing upper limb motor control
- Subject unable to understand or perform the required motor tasks
- Psychotropic polypharmacy (regular use of neuroleptics, anti-epileptics, benzodiazepines, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: anodal cTDCS group
|
anodal cTDCS
cathodal cTDCS
|
|
Active Comparator: cathodal cTDCS group
|
anodal cTDCS
cathodal cTDCS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MDS-UPDRS (Unit on a scale)
Time Frame: day 1 to day 10 (MDS-UPDRS III) day 1 to day 40 (MDS-UPDRS Part I, II and IV)
|
MDS-UPDRS Part III MDS-UPDRS Part I, II and IV
|
day 1 to day 10 (MDS-UPDRS III) day 1 to day 40 (MDS-UPDRS Part I, II and IV)
|
|
CCAS (Unit on a scale)
Time Frame: day 1 and day 10
|
CCAS scale
|
day 1 and day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and tolerability of ctDCS (Unit on a scale)
Time Frame: from day 1 to day 10
|
participant-reported outcomes regarding the ease of self-administration and the presence of side effects are collected through a dedicated questionnaire.
|
from day 1 to day 10
|
|
Scale evaluation anxiety (Unit on a scale)
Time Frame: day 1 and day 40
|
anxiety as evaluated by Generalized Anxiety Disorder-7 (GAD-7)
|
day 1 and day 40
|
|
Scale evaluating depression (Unit on a scale)
Time Frame: day 1 and day 40
|
depression as evaluated by Patient Health Questionnaire-9 (PHQ-9 )
|
day 1 and day 40
|
|
Quality of life (Unit on a scale)
Time Frame: day 1 and day 40
|
quality of life as evaluated by Parkinson's Disease Questionnaire-39 (PDQ-39)
|
day 1 and day 40
|
|
Scale evaluation anxiety (Unit on a scale)
Time Frame: day 1 and day 40
|
anxiety as evaluated by Beck Anxiety Inventory (BAI)
|
day 1 and day 40
|
|
Scale evaluating depression (Unit on a scale)
Time Frame: day 1 and day 40
|
depression as evaluated by Beck Depression Inventory (BDI)
|
day 1 and day 40
|
|
Quality of life (Unit on a scale)
Time Frame: day 1 and day 40
|
quality of life as evaluated by European Quality of Life 5 Dimensions (EQ-5D)
|
day 1 and day 40
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Manto M, Argyropoulos GPD, Bocci T, Celnik PA, Corben LA, Guidetti M, Koch G, Priori A, Rothwell JC, Sadnicka A, Spampinato D, Ugawa Y, Wessel MJ, Ferrucci R. Consensus Paper: Novel Directions and Next Steps of Non-invasive Brain Stimulation of the Cerebellum in Health and Disease. Cerebellum. 2022 Dec;21(6):1092-1122. doi: 10.1007/s12311-021-01344-6. Epub 2021 Nov 23.
- Cabaraux P, Georgiev C, Destrebecq V, Supiot F, Munoz NY, Hakkak Moghadam Torbati A, Digileva D, Iannotta A, Yildiran Carlak E, Mongold S, Bourguignon M, Naeije G. Effects of anodal cerebellar transcranial direct current stimulation on motor symptoms and cerebellar inhibition in Parkinson's disease: A sham-controlled cross-over study. Parkinsonism Relat Disord. 2026 Mar;144:108202. doi: 10.1016/j.parkreldis.2026.108202. Epub 2026 Jan 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B40620224000258 ; P2024/328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PARKINSON DISEASE (Disorder)
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
San Francisco Neurology and Sleep CenterNot yet recruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
Universidad Rey Juan CarlosAsociación Parkinson MadridRecruitingPARKINSON DISEASE (Disorder)Spain
-
Northumbria UniversityNorth Tyneside General Hospital; Northumbria Healthcare NHS Foundation Trust; Northumberland, Tyne and Wear NHS Foundation TrustNot yet recruitingPARKINSON DISEASE (Disorder)United Kingdom
-
Cleveland State UniversityMpb Charitable Foundation; InMotion Wellness Center; Beth A Ekelman, PhD, JD,... and other collaboratorsRecruiting
-
Stoparkinson Healthcare Systems LLCRecruitingPARKINSON DISEASE (Disorder)Turkey (Türkiye)
Clinical Trials on cTDCS
-
Universidade Federal de PernambucoUnknownCerebellar Ataxia | Balance | Cerebellum; InjuryBrazil
-
Universitätsklinikum Hamburg-EppendorfCompletedIsolated Cervical DystoniaGermany
-
University of IowaWithdrawnParkinson Disease | Healthy AdultUnited States
-
University of SharjahNot yet recruitingMultiple SclerosisUnited Arab Emirates