Skip to content

Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06297538
Enrollment
84
Registered
2024-03-07
Start date
2023-04-29
Completion date
2026-04-29
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson's disease, Motor cortex, Transcranial magnetic stimulation

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.

Interventions

Transcranial alternating current stimulation (tACS) will be delivered using a BrainSTIM (EMS, Italy) connected to two electrodes (5x5cm) enclosed in sponges soaked with saline solution. One electrode will be centred over the first dorsal interosseus (FDI) hotspot and the other over P3. tACS will be delivered at peak-to-peak amplitude of 1 milliampere (mA), and with 3-seconds ramp-up and down periods. The stimulation frequency will be 70 Hz, as representative of the endogenous motor network-related gamma frequency.

Sham-tACS will consist of ramp-up and down periods and only 1-second stimulation at 1 mA amplitude.

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico
CollaboratorOTHER
I.R.C.C.S. Fondazione Santa Lucia
CollaboratorOTHER
Neuromed IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* PD diagnosis

Exclusion criteria

* severe cognitive and psychiatric comorbidities * H&Y\>3 * 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in bradykinesia features as objectively assessed by kinematic techniquespost 5, 15 and 30 minutesThe velocity of finger tapping movements will be kinematically measured and expressed in degrees/second.
Changes in motor learning performance as objectively assessed by kinematic techniquespost 5, 15 and 30 minutesThe acceleration peak of finger index abductions will me kinematically measured and expressed as millimeters/seconds

Countries

Italy

Contacts

Primary ContactGiulia Paparella
giulia.paparella@uniroma1.it3384780752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026