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Clinical Trials/NCT06297538
NCT06297538
Recruiting
Not Applicable

Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications

Neuromed IRCCS1 site in 1 country84 target enrollmentApril 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Neuromed IRCCS
Enrollment
84
Locations
1
Primary Endpoint
Changes in bradykinesia features as objectively assessed by kinematic techniques
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.

Registry
clinicaltrials.gov
Start Date
April 29, 2023
End Date
April 29, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neuromed IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Giulia Paparella

Principal Investigator

Neuromed IRCCS

Eligibility Criteria

Inclusion Criteria

  • PD diagnosis

Exclusion Criteria

  • severe cognitive and psychiatric comorbidities
  • levodopa-induced dyskinesia and tremor-dominant phenotype
  • history of additional neuropsychiatric disorders
  • intake of medications acting on brain excitability or plasticity
  • contraindications to non-invasive brain stimulation

Outcomes

Primary Outcomes

Changes in bradykinesia features as objectively assessed by kinematic techniques

Time Frame: post 5, 15 and 30 minutes

The velocity of finger tapping movements will be kinematically measured and expressed in degrees/second.

Changes in motor learning performance as objectively assessed by kinematic techniques

Time Frame: post 5, 15 and 30 minutes

The acceleration peak of finger index abductions will me kinematically measured and expressed as millimeters/seconds

Study Sites (1)

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