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Parkinson's Disease (PD)tACS_PD_TRNCT06993571

Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Parkinson's Disease Tremor

A study testing Active-tACS and Unlocked-tACS in people with Parkinson's Disease (PD) and Tremor, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by different motor symptoms, including tremor, which is particularly difficult to manage. Common treatments, such as dopaminergic therapy, can have limitations in efficacy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease (PD), Tremor
What is being tested?
Active-tACS and Unlocked-tACS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteGermany
Study dates
16 Apr 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Parkinson's disease based on UK Brain Bank criteria
  • Patient exhibiting moderate to severe hand tremor
  • Provision written informed consent by the patient

Who cannot join

  • History of other neurological disorders such as vascular malformations, ischemic or haemorrhagic stroke, cerebral neoplasia, epilepsy, or major psychiatric illness
  • Existence of heart pacemaker or metal implants in the body
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Simone Zittel, Dr. med. contact

+49 40 7410 53770

s.zittel-dirks@uke.de

Germany1 site, 1 recruiting
  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Simone Zittel, Dr. med., +49 40 7410 53770, s.zittel-dirks@uke.de

    Fatemeh Sadeghi, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: Closed-loop Phase-adaptive Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in the Cerebello-thalamo-cortical Network to Reduce Parkinson's Disease Tremor

Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by different motor symptoms, including tremor, which is particularly difficult to manage. Common treatments, such as dopaminergic therapy, can have limitations in efficacy. Recent advancements in non-invasive brain stimulation, specifically phase-adaptive transcranial alternating current stimulation (tACS), offer a promising approach to reduce PD tremor. In the current project, a newly developed closed-loop system delivers precisely synchronized cerebellar tACS by aligning stimulation with the intrinsic hand tremor signal. The study will assess the efficacy of this novel approach to reduce hand tremor in PD patients.

Read the detailed description

Parkinson's disease (PD) is the second most common neurodegenerative disorder, characterized by progressive neurodegeneration, especially in the substantia nigra. Clinically, PD is characterized by motor impairment, including bradykinesia, rigidity, postural instability, and tremor, with hand trem-or being particularly challenging due to its heterogeneity and the incomplete understanding of its underlying neurophysiological mechanisms. Emerging evidence suggests that pathological activity in the cortico-thalamo-cortical (CTC) network is associated with PD tremor amplitude. In recent years, the cerebellum has been recognized for its direct involvement in tremor dynamics within the CTC network. Addressing the abnormal oscillatory activity within this network could potentially modu-late tremor pathophysiology.

Current therapeutic approaches for PD tremor focus on dopaminergic replacement, however some patients exhibit minimal response to this treatment. Deep brain stimulation (DBS) has shown effi-cacy in alleviating tremor, but its invasive nature and associated risks limit its widespread use. Con-sequently, there has been growing interest in non-invasive brain stimulation techniques as poten-tial alternatives for tremor management. Among these techniques, transcranial alternating current stimulation (tACS) has gained significant attention due to its ability to modulate endogenous brain oscillations. Phase-specific tACS, which involves aligning the stimulation phase with the intrinsic tremor rhythms, has demonstrated potential in entraining and reducing PD tremor. However, the application of this technique has been constrained by the complexities associated with phase ad-justment algorithms and the need for a responsive closed-loop system capable of real-time phase synchronization.

For the current project, a novel closed-loop device has been developed together with the collabo-rator neuroConn GmbH that is specifically designed to target PD tremor. This device is capable of real-time monitoring of hand tremor, rapid signal processing, and delivering phase-locked tACS within safe operational parameters. The central hypothesis is that phase-locked tACS of the cere-bellum can modulate the oscillatory dynamics within the CTC network and thereby reduce tremor amplitude in PD patients.

The study will involve PD patients with moderate to severe hand tremor, as assessed using the Movement Disorders Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The experimental design involves two sessions, both utilizing closed-loop tACS at an intensity of 2 to 4 mA.

In each session, a baseline recording of PD hand tremor will be collected before stimulation. In the first session, the phase alignment between the tremor and tACS signals will be systematically varied across 60° phase bins; plus a sham (zero stimulation amplitude) and an unlocked stimulation proto-col (open-loop). The data from this session will be analyzed to determine the optimal phase align-ment. In the second session, tACS will be applied using the optimal phase alignment identified in the first session. After each block of stimulation, a post-stimulation baseline recording will be con-ducted to evaluate the immediate effects of the intervention. This design enables the assessment of phase-specific effects of closed-loop tACS on PD hand tremor.

This study aims to assess the extent and duration of tremor reduction achieved by closed-loop phase-adaptive cerebellar tACS, enhancing our understanding of the CTC network and potentially offering new insights into non-invasive therapeutic strategies for managing PD tremor.

Being tested
Active-tACS, Sham-tACS, Unlocked-tACS
Keywords
Parkinson's disease, Hand tremor, Transcranial alternating current stimulation, Non-invasive brain stimulation, Closed-loop stimulation, Phase-adaptive stimulation, Tremor entrainment
Medical subject headings
Parkinson Disease, Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active-tACSDevice

    30 seconds of closed-loop tACS at 2-4 mA, with 6 alternating phase alignments and 1-3 repetitions. Phase alignment is adjusted to the patient's tremor frequency and rhythm in real time. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The stimulation begins with a 3-second ramp-up and ends with a 3-second ramp-down.

  • Sham-tACSDevice

    30 seconds of tACS at 0 mA and 1-3 repetitions. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The sham protocol begins with a 3-second ramp-up and ends with a 3-second ramp-down.

  • Unlocked-tACSDevice

    30 seconds of open-loop tACS at 2-4 mA, with no phase alignments and 1-3 repetitions. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The stimulation begins with a 3-second ramp-up and ends with a 3-second ramp-down.

Study groups in NCT06993571
Study groupRoleWhat they receive
Active-tACSExperimentalPatients receive an active tACS stimulation with 2-4 mA amplitude
Receives: Device: Active-tACS
Sham-tACSSham comparatorPatients receive a tACS stimulation with 0 mA amplitude
Receives: Device: Sham-tACS
Unlocked-tACSActive comparatorPatients receive an active tACS stimulation with 2-4 mA amplitude but without phase alignment between tremor and tACS
Receives: Device: Unlocked-tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in tremor amplitude

    A significant change in the amplitude of hand tremor as the active tACS stimulation with the optimum phase alignment is being delivered. Tremor amplitude is computed offline in MATLAB.

    Measured: During the stimulation

Secondary outcomes (1)
  1. Tremor entrainment

    Changes in tremor characteristics including instantaneous frequency due to active stimulation

    Measured: During the stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start16 Apr 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Crossover
Model description
Each participant will receive active, sham, and control stimulation in a randomized manner.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06993571
Sponsor's protocol ID
Cereb_tACS_PD_TR
Acronym
tACS_PD_TR
Status last verified
Aug 2026
First submitted
19 May 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to data protection policies

Questions about this trial

What is this clinical trial studying?

A study testing Active-tACS and Unlocked-tACS in people with Parkinson's Disease (PD) and Tremor, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Simone Zittel, Dr. med. (+49 40 7410 53770, s.zittel-dirks@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in tremor amplitude (time frame: During the stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Sep 2026.

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