| Field |
Value |
| Trial ID |
NCT07381907 |
| Phase |
Phase 2 |
| Status |
Recruiting |
| Condition |
Parkinson's Disease |
| Intervention |
tDCS + Nordic Walking combined therapy |
| Sponsor |
[University Medical Center] |
| Start Date |
2025 |
| Completion Date |
2027 |
¶ Background and Rationale
¶ Parkinson's Disease and Motor Symptoms
Parkinson's disease (PD) is characterized by progressive motor symptoms including:
- Bradykinesia: Slowness of movement
- Rigidity: Muscle stiffness
- Resting tremor: Involuntary shaking
- Postural instability: Balance and gait difficulties
Current pharmacological treatments (levodopa, dopamine agonists) provide symptomatic relief but are associated with long-term complications including motor fluctuations and dyskinesias.
tDCS is a non-invasive brain stimulation technique that applies a low-intensity electrical current through the scalp to modulate cortical excitability:
flowchart TD
AtDCS["AtDCS Application"] --> B["Anodal stimulation<br/>increases cortical excitability"]
A --> C["Cathodal stimulation<br/>decreases cortical excitability"]
B --> D["Motor cortex activation"]
D --> E["Enhanced motor output"]
E --> F["Improved motor function"]
C --> G["Inhibitory modulation<br/>in hyperactive circuits"]
G --> F
Mechanism of Action:
- Alters neuronal membrane potentials
- Modulates NMDA receptor activity
- Increases BDNF expression
- Enhances neuroplasticity
tDCS in PD:
- Targets motor cortex (M1) and prefrontal cortex
- Improves UPDRS scores by 10-25%
- May reduce levodopa-induced dyskinesias
- Non-invasive with minimal side effects
Nordic walking is an enhanced walking technique that uses specially designed poles to engage the upper body:
- Full-body exercise: Engages arms, core, and legs
- Biomechanical benefits: Improved posture, stride length, gait velocity
- Cardiovascular training: Higher heart rate than conventional walking
- Balance improvement: Enhanced proprioceptive feedback
- Psychological benefits: Reduced depression and anxiety
The combination of tDCS and Nordic walking addresses multiple aspects of PD pathophysiology:
- Synergistic neuroplasticity: tDCS enhances motor cortex excitability while exercise promotes BDNF-mediated neuroplasticity
- Motor circuit modulation: Combined approach targets both central (tDCS) and peripheral (exercise) mechanisms
- Non-pharmacological: Provides alternative for patients with medication limitations
- Comprehensive rehabilitation: Addresses motor, balance, and gait aspects simultaneously
- Design: Randomized, sham-controlled, double-blind
- Duration: 12 weeks intervention + 24-week follow-up
- Population: 120 participants with early-to-mid stage PD (Hoehn & Yahr 1-3)
- Allocation: 1:1:1:1 (4 arms)
| Arm |
Intervention |
Description |
| 1 |
Active tDCS + Nordic Walking |
Real tDCS + supervised Nordic walking |
| 2 |
Active tDCS + Standard Walking |
Real tDCS + conventional walking |
| 3 |
Sham tDCS + Nordic Walking |
Inactive tDCS + supervised Nordic walking |
| 4 |
Sham tDCS + Standard Walking |
Inactive tDCs + conventional walking |
- Diagnosis of Parkinson's disease (UK Brain Bank criteria)
- Hoehn & Yahr stage 1-3
- Stable PD medication for ≥4 weeks
- Able to walk independently (with or without assistive device)
- No prior tDCS exposure
- MMSE score ≥24
- History of seizures or epilepsy
- Metal implants in the brain or skull
- Cardiac pacemaker or other electronic devices
- Severe cardiovascular disease
- Orthopedic limitations preventing walking
- Current participation in other rehabilitation trials
| Measure |
Description |
Timing |
| MDS-UPDRS Part III |
Motor examination score |
Baseline, Week 12, Week 36 |
| 6-Minute Walk Test |
Gait endurance |
Baseline, Week 12, Week 36 |
| 10-Meter Walk Test |
Gait velocity |
Baseline, Week 12, Week 36 |
- Timed Up and Go (TUG): Functional mobility
- Berg Balance Scale: Balance assessment
- Freezing of Gait Questionnaire: FOG severity
- PIGD Score: Postural instability/gait difficulty subscore
- PDQ-39: Quality of life
- Beck Depression Inventory: Depression severity
- MDS-UPDRS Part I: Non-motor experiences of daily living
- Epworth Sleepiness Scale: Sleep quality
- Motor evoked potentials (MEPs): Corticospinal excitability
- Resting motor threshold: Cortical excitability parameters
- Adverse event monitoring
- tDCS-related side effects (skin irritation, headache)
- Exercise-related injuries
- Falls diary
| Parameter |
Value |
| Current intensity |
2 mA |
| Duration |
20 minutes/session |
| Frequency |
5 sessions/week for 4 weeks (20 sessions) |
| Electrode size |
35 cm² |
| Placement |
M1 (motor cortex) - anode, contralateral supraorbital - cathode |
- Pre-assessment (vital signs)
- tDCS application (20 min)
- Rest period (10 min)
- Exercise intervention (40 min)
- Post-session assessment
| Phase |
Duration |
Frequency |
Focus |
| Week 1-2 |
30 min |
3x/week |
Technique training |
| Week 3-4 |
40 min |
3x/week |
Progressive walking |
| Week 5-8 |
45 min |
3x/week |
Interval training |
| Week 9-12 |
50 min |
3x/week |
Endurance building |
- Pole grip: Ergonomic handle, diagonal grip
- Pole placement: 45° angle behind body
- Arm movement: Opposite arm-leg coordination
- Core engagement: Trunk rotation with poles
- Stride length: Extended push-off phase
flowchart TD
subgraph tDCS["tDCS Effects"]
A1["Anodal M1 stimulation"] --> A2["↑ Glutamatergic activity"]
A2 --> A3["Enhanced LTP"]
A3 --> A4["Increased cortical excitability"]
end
subgraph Exercise["Nordic Walking Effects"]
B1["Aerobic exercise"] --> B2["↑ BDNF expression"]
B2 --> B3["Neurogenesis"]
B3 --> B4["Improved neuroplasticity"]
end
A4 --> C["Synergistic neuroplasticity"]
B4 --> C
C --> D["↓ Motor symptoms"]
D --> E["↓ Bradykinesia"]
D --> F["↓ Gait impairment"]
D --> G["↓ Postural instability"]
- BDNF-tDCS synergy: Exercise-induced BDNF enhances tDCS-driven plasticity
- Motor cortex priming: tDCS before exercise improves motor learning
- Gating mechanisms: Combined approach may improve sensorimotor integration
- Circuit remodeling: Both modalities promote adaptive cortical reorganization
- MDS-UPDRS Part III: Expected improvement of 8-12 points vs. baseline
- 6-Minute Walk Test: Expected 15-25% improvement in distance
- 10-Meter Walk Test: Expected 10-15% improvement in velocity
- TUG time: Expected 10-20% reduction
- Berg Balance Scale: Expected 5-10 point improvement
- PDQ-39: Expected 8-15% improvement in mobility domain
- Sustained motor improvements
- Reduced fall frequency
- Improved quality of life
¶ Current Status and Timeline
| Milestone |
Expected Date |
| First participant enrolled |
Q1 2025 |
| Enrollment completion |
Q4 2026 |
| Primary analysis |
Q2 2027 |
| Results publication |
Q4 2027 |
¶ Research Gaps and Future Directions
- Optimizing stimulation parameters: Comparing different tDCS intensities and electrode configurations
- Biomarker development: Using neuroimaging to predict treatment response
- Personalized protocols: Tailoring tDCS-exercise combination based on disease stage
- Mechanistic studies: Investigating BDNF and neuroplasticity markers
- Fregni & Pascual-Leone, Technology insight: noninvasive brain stimulation in neurology (2007)
- Nardone et al., tDCS for Parkinson's disease (2021)
- Pinto et al., Nordic walking in Parkinson's disease (2013)
- Schwarzenberg et al., tDCS combined with exercise in PD (2019)
- Moreau et al., Nordic walking improves gait in PD (2012)
- Lamotte et al., tDCS and aerobic exercise synergy (2020)
- MDS-UPDRS: Movement Disorder Society (2008)
- Bloem et al., Exercise and Parkinson's disease (2020)