Parkinson DiseaseNCT06297538
Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation
A study testing gamma transcranial alternating current stimulation (tACS) in people with Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- gamma transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2023to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli
Giulia Paparella, 3384780752
About this study
Official title: Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications
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.
- Conditions
- Parkinson Disease
- Being tested
- gamma transcranial alternating current stimulation (tACS), sham transcranial alternating current stimulation (tACS)
- Keywords
- Parkinson's disease, Motor cortex, Transcranial magnetic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma transcranial alternating current stimulation (tACS)Device
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 transcranial alternating current stimulation (tACS)Device
Sham-tACS will consist of ramp-up and down periods and only 1-second stimulation at 1 mA amplitude.
| Study group | Role | What they receive |
|---|---|---|
| gamma transcranial alternating current stimulation | Experimental | Not described Receives: Device: gamma transcranial alternating current stimulation (tACS) |
| sham transcranial alternating current stimulation | Sham comparator | Not described Receives: Device: sham transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bradykinesia features as objectively assessed by kinematic techniques
The velocity of finger tapping movements will be kinematically measured and expressed in degrees/second.
Measured: post 5, 15 and 30 minutes
Changes in motor learning performance as objectively assessed by kinematic techniques
The acceleration peak of finger index abductions will me kinematically measured and expressed as millimeters/seconds
Measured: post 5, 15 and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start29 Apr 2023
- Primary completion29 Oct 2024 (estimated)
- Study completion29 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, I.R.C.C.S. Fondazione Santa Lucia
- Responsible party
- Principal investigator, Giulia Paparella, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297538
- Sponsor's protocol ID
- GR-2021-12372323
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paparella G, Costa D, De Riggi M, Angelini L, Birreci D, Pietracupa S, Cannavacciuolo A, Guerra A, Bologna M. Driving motor cortex oscillations restores plasticity and improves bradykinesia features in Parkinson's disease. NPJ Parkinsons Dis. 2026 May 12. doi: 10.1038/s41531-026-01373-0. Online ahead of print.
PubMed 42115691
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications
- ClinicalTrials.gov ID
- NCT06297538
- Acronym / sponsor ID
- GR-2021-12372323
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Motor cortex, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, I.R.C.C.S. Fondazione Santa Lucia
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 29 Oct 2024 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gamma transcranial alternating current stimulation | Experimental | Device: gamma transcranial alternating current stimulation (tACS) |
| sham transcranial alternating current stimulation | Sham comparator | Device: sham transcranial alternating current stimulation (tACS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PD diagnosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamma transcranial alternating current stimulation (tACS)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. | Device | gamma transcranial alternating current stimulation |
| sham transcranial alternating current stimulation (tACS)Sham-tACS will consist of ramp-up and down periods and only 1-second stimulation at 1 mA amplitude. | Device | sham transcranial alternating current stimulation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 42115691Paparella G, Costa D, De Riggi M, Angelini L, Birreci D, Pietracupa S, Cannavacciuolo A, Guerra A, Bologna M. Driving motor cortex oscillations restores plasticity and improves bradykinesia features in Parkinson's disease. NPJ Parkinsons Dis. 2026 May 12. doi: 10.1038/s41531-026-01373-0. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamma transcranial alternating current stimulation (tACS) in people with Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Paparella (3384780752, giulia.paparella@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bradykinesia features as objectively assessed by kinematic techniques (time frame: post 5, 15 and 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.