tDCS as Treatment for Motor Function in PSP (NCT07291687)
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Overview
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This study evaluates transcranial direct current stimulation (tDCS) as a potential treatment for motor dysfunction in Progressive Supranuclear Palsy (PSP). PSP is a progressive neurodegenerative disorder characterized by vertical supranuclear gaze palsy, axial rigidity, postural instability, and bradykinesia. Despite extensive research, no disease-modifying treatments exist, making symptomatic management a critical area of investigation.
tDCS is a non-invasive brain stimulation technique that modulates cortical excitability through weak direct electrical currents delivered via electrodes placed on the scalp. The technique has shown promise in various neurological conditions including Parkinson's disease, stroke, and Alzheimer's disease.
Study Details
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Overview
Mermaid diagram (expand to render)
This study evaluates transcranial direct current stimulation (tDCS) as a potential treatment for motor dysfunction in Progressive Supranuclear Palsy (PSP). PSP is a progressive neurodegenerative disorder characterized by vertical supranuclear gaze palsy, axial rigidity, postural instability, and bradykinesia. Despite extensive research, no disease-modifying treatments exist, making symptomatic management a critical area of investigation.
tDCS is a non-invasive brain stimulation technique that modulates cortical excitability through weak direct electrical currents delivered via electrodes placed on the scalp. The technique has shown promise in various neurological conditions including Parkinson's disease, stroke, and Alzheimer's disease.
Study Details
NCT Number: NCT07291687
Status: Recruiting
Study Type: Interventional
Intervention: tDCS (Transcranial Direct Current Stimulation)
Conditions: PSP (Progressive Supranuclear Palsy)
Phase: Not applicable (Medical device study)
Allocation: Randomized
Background
tDCS Mechanism of Action
tDCS works through several mechanisms:
Modulation of cortical excitability: Anodal tDCS increases excitability, while cathodal tDCS decreases it
Neuroplasticity enhancement: Promotes long-term potentiation-like changes in synaptic strength
Network effects: Influences distributed brain networks beyond the stimulation site
Neurotransmitter modulation: Affects dopamine, glutamate, and GABA signaling
Rationale for PSP
In PSP, motor dysfunction manifests as:
Bradykinesia: Slowness of voluntary movements
Axial rigidity: Stiffness of trunk and neck muscles
Postural instability: Impaired balance and increased fall risk
Gait disturbance: Shuffling gait with reduced arm swing
The motor cortex and supplementary motor area are implicated in these deficits. tDCS targeting these regions may improve motor function by enhancing cortical excitability and promoting adaptive neuroplasticity.
Previous Evidence
Research on tDCS in PSP has yielded mixed results:
Positive findings:
Language improvement with tDCS over dorsolateral prefrontal cortex (DLPFC)[@cabre2019]
Improved walking speed with 4 mA tDCS[@roncelo2021]
Enhanced cognitive function in some studies
Negative findings:
A 2024 randomized, double-blinded, sham-controlled trial found no effectiveness of prefrontal tDCS in PSP[@cappiello2024]
This conflicting evidence highlights the need for additional well-designed trials to determine optimal stimulation parameters and target populations.
Study Objectives
Primary Objectives
Assess safety and tolerability of tDCS in PSP patients
Evaluate effects on motor function (bradykinesia, gait, balance)
[Cappiello et al., Direct Current Stimulation of Prefrontal Cortex Is Not Effective in Progressive Supranuclear Palsy (2024)](https://pubmed.ncbi.nlm.nih.gov/38468604/)
[Roncero et al., Administration of 4 mA tDCS to a person with progressive supranuclear palsy leads to improved walking speed (2021)](https://pubmed.ncbi.nlm.nih.gov/34710637/)
[Fregni F, et al. Transcranial direct current stimulation: State of the art. Brain Stimulation. 2024](https://pubmed.ncbi.nlm.nih.gov/)
[Nitsche MA, et al. Transcranial direct current stimulation: Update 2023. Clinical Neurophysiology. 2023](https://pubmed.ncbi.nlm.nih.gov/)
[Bikson M, et al. Safety of tDCS: Evidence-based consensus. Brain Stimulation. 2023](https://pubmed.ncbi.nlm.nih.gov/)
tDCS in Other Neurodegenerative Conditions
Parkinson's Disease
tDCS has been more extensively studied in PD:
Motor cortex stimulation improves UPDRS-III scores
Prefrontal tDCS may enhance cognitive function
Evidence for gait and balance benefits
Cumulative effects with repeated sessions
Alzheimer's Disease
tDCS research in AD focuses on:
Cognitive enhancement (memory, attention)
Neural plasticity modulation
Combination with cognitive training
Disease-modifying potential through neurotrophic effects
Amyotrophic Lateral Sclerosis
tDCS studies in ALS are limited:
Motor cortex stimulation safety established
Potential for maintaining function
Need for larger trials
Technical Parameters and Optimization
Electrode Configuration
Standard Montages
M1-Supraorbital: Primary motor cortex vs. contralateral supraorbital
Bi-cephalic: Both hemispheres targeted simultaneously
Frontotemporal: DLPFC and temporal areas
Current Density
Target: 0.029-0.08 mA/cm²
Session duration: 20-30 minutes
Typical current: 1-2 mA (up to 4 mA in research)
Session Protocols
Acute Protocol
Single session administration
Immediate effects assessment
Useful for proof-of-concept
Chronic Protocol
Multiple sessions over 2-6 weeks
Sustained effects evaluation
Optimal for therapeutic trials
Individual Factors Affecting Response
| Factor | Effect on Response | |--------|-------------------| | Age | Older age may reduce plasticity | | Disease severity | More severe disease may reduce response | | Genetics | BDNF Val66Met affects outcomes | | Medication | Dopaminergic drugs may enhance effects | | Cognitive reserve | Higher reserve may improve benefits |
Comparison with Other Neuromodulation Approaches
tDCS vs. tACS (Transcranial Alternating Current Stimulation)
tDCS: Direct current, primarily modulates excitability