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Enrolling by invitation NCT07548801

Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease

No phase Interventional PARKINSON DISEASE (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cTDCS, cTDCS.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Can Cerebellar Transcranial Direct Current Stimulation be Regarded as a Rational Therapeutic Option for Treating Parkinson's Disease ?

Overview

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

Interventions

  • Device cTDCS
    anodal cTDCS
  • Device cTDCS
    cathodal cTDCS

Primary outcome measures

  • 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)]
  • CCAS (Unit on a scale) [Time frame: day 1 and day 10]
Secondary outcome measures (7)
  • Feasibility and tolerability of ctDCS (Unit on a scale) [Time frame: from day 1 to day 10]
  • Scale evaluation anxiety (Unit on a scale) [Time frame: day 1 and day 40]
  • Scale evaluating depression (Unit on a scale) [Time frame: day 1 and day 40]
  • Quality of life (Unit on a scale) [Time frame: day 1 and day 40]
  • Scale evaluation anxiety (Unit on a scale) [Time frame: day 1 and day 40]
  • Scale evaluating depression (Unit on a scale) [Time frame: day 1 and day 40]
  • Quality of life (Unit on a scale) [Time frame: day 1 and day 40]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Hopital Erasme — Brussels

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. PMID 34813040
  • 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. PMID 41616661

Identifiers

NCT: NCT07548801 · B40620224000258 ; P2024/328

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗