Clinical trial NCT04811066: Motor Learning and Multi-session tDCS in Parkinson's Disease
Official title: The Effect of Multi-session Transcranial Direct Current Stimulation Applied Over the Primary Motor Cortex on Motor Sequence Learning in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Transcranial direct current stimulation
Motor sequence learning
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study seeks to examine the efficacy of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.

Detailed description: Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions.

The present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.

Eligibility criteria: Inclusion Criteria:

* Right-handed (Edinburgh Handedness Inventory; ≥50)
* Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
* Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
* On stable dopaminergic medication

Exclusion Criteria:

* History of stroke
* Comorbidity
* Cephalic implants

Primary outcomes:
measure: Change from baseline: sequential finger tapping performance
timeFrame: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
measure: Change from baseline: shape-counting error
timeFrame: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
Secondary outcomes:
measure: Change from baseline: oxygenated haemoglobin response
timeFrame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
measure: Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)
timeFrame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
measure: Change from baseline: upper limb motor task performance
timeFrame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
measure: Change from baseline: Purdue pegboard task performance
timeFrame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Hung Hom
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Margaret Mak, Dr
role: PRINCIPAL_INVESTIGATOR
References: