Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease

NCT07548801 | Enrolling By Invitation

• 1 other identifier: B40620224000258 ; P2024/328
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson's disease; cerebellar transcranial direct current stimulation; MDS-UPDRS; CCAS scale

Outcome Measures

Primary Outcomes (2)

• MDS-UPDRS (Unit on a scale)

  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)

  CCAS scale

  day 1 and day 10

Secondary Outcomes (7)

• Feasibility and tolerability of ctDCS (Unit on a scale)

  from day 1 to day 10

• Scale evaluation anxiety (Unit on a scale)

  day 1 and day 40

• Scale evaluating depression (Unit on a scale)

  day 1 and day 40

• Quality of life (Unit on a scale)

  day 1 and day 40

• Scale evaluation anxiety (Unit on a scale)

  day 1 and day 40

Study Arms (2)

anodal cTDCS group

EXPERIMENTAL

Device: cTDCS

cathodal cTDCS group

ACTIVE COMPARATOR

Device: cTDCS

Interventions

cTDCS DEVICE

anodal cTDCS

anodal cTDCS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Fonds de la Recherche Scientifique (fnrs): collaborator

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

Location

Related Publications (2)

• 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.

  PMID: 34813040 BACKGROUND

• 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.

  PMID: 41616661 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: MDS-UPDRS III is recorded by a blinded neurologist CCAS is recorded by a blinded neuropsychologist
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Three months post-stimulation, patients will cross over to the other study group

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 23, 2026
• Study Start: September 24, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)