Motor Learning and Multi-session tDCS in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811066
• Other study ID #: HSEARS20200203002
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: October 2, 2021

Study information

• Verified date: March 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2, 2021
• Est. primary completion date: October 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Transcranial direct current stimulation
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong	Hung Hom

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline: sequential finger tapping performance	A skill index reflecting the accuracy and speed that participants perform a specified finger tapping sequence.	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.
Primary	Change from baseline: shape-counting error	The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.	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	Change from baseline: oxygenated haemoglobin response	Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.	Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Secondary	Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)	Participants physical function is assessed according to the criteria of the Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3). Minimum value = 0, maximum value = 132. Lower scores indicate a better outcome.	Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Secondary	Change from baseline: upper limb motor task performance	Timed sequential movement of the arm and hand. The participant sits upright on a chair that has no arm support with their arms relaxed by their side. The time taken to perform the following sequence 10 times is recorded: 1. Close and open hand, 2) flex elbow, 3) close and open hand, 4) extend elbow. Right and left arms are assessed separately.	Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Secondary	Change from baseline: Purdue pegboard task performance	Participants are required to pick up a metal peg and place the peg in a specified row of holes. Pegs must be placed one at a time. The maximum number of pegs placed within 30 seconds is recorded. The assessment is repeated three times for each hand. Each hand is assessed separately.	Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention