PARKINSON DISEASE (Disorder)
Conditions
Keywords
Parkinson's disease, cerebellar transcranial direct current stimulation, MDS-UPDRS, CCAS scale
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
Interventions
DEVICEcTDCS
anodal cTDCS
Sponsors
Université Libre de Bruxelles
Fonds de la Recherche Scientifique (fnrs)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
MDS-UPDRS III is recorded by a blinded neurologist CCAS is recorded by a blinded neuropsychologist
Intervention model description
Three months post-stimulation, patients will cross over to the other study group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS (Unit on a scale) | 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 |
| CCAS (Unit on a scale) | day 1 and day 10 | CCAS scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and tolerability of ctDCS (Unit on a scale) | 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. |
| Scale evaluation anxiety (Unit on a scale) | day 1 and day 40 | anxiety as evaluated by Generalized Anxiety Disorder-7 (GAD-7) |
| Scale evaluating depression (Unit on a scale) | day 1 and day 40 | depression as evaluated by Patient Health Questionnaire-9 (PHQ-9 ) |
| Quality of life (Unit on a scale) | day 1 and day 40 | quality of life as evaluated by Parkinson's Disease Questionnaire-39 (PDQ-39) |
Countries
Belgium
Outcome results
None listed