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.
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.
Germany1 site, 1 recruiting
- 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.
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.
- Conditions
- Parkinson's Disease (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 group | Role | What they receive |
|---|---|---|
| Active-tACS | Experimental | Patients receive an active tACS stimulation with 2-4 mA amplitude Receives: Device: Active-tACS |
| Sham-tACS | Sham comparator | Patients receive a tACS stimulation with 0 mA amplitude Receives: Device: Sham-tACS |
| Unlocked-tACS | Active comparator | Patients 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.
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)
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.
- First posted29 May 2025
- Study start16 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Zittel, Universitätsklinikum Hamburg-Eppendorf
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06993571
- Acronym / sponsor ID
- tACS_PD_TR / Cereb_tACS_PD_TR
- Conditions
- Parkinson's Disease (PD), Tremor
- Keywords
- Parkinson's disease, Hand tremor, Transcranial alternating current stimulation, Non-invasive brain stimulation, Closed-loop stimulation, Phase-adaptive stimulation, Tremor entrainment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 May 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will receive active, sham, and control stimulation in a randomized manner.
| Arm | Type | Receives |
|---|---|---|
| Active-tACS | Experimental | Device: Active-tACSPatients receive an active tACS stimulation with 2-4 mA amplitude |
| Sham-tACS | Sham comparator | Device: Sham-tACSPatients receive a tACS stimulation with 0 mA amplitude |
| Unlocked-tACS | Active comparator | Device: Unlocked-tACSPatients receive an active tACS stimulation with 2-4 mA amplitude but without phase alignment between tremor and tACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Active-tACS30 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. | Device | Active-tACS |
| Sham-tACS30 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. | Device | Sham-tACS |
| Unlocked-tACS30 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. | Device | Unlocked-tACS |
Primary outcome
Change in tremor amplitude
Time frame: During the stimulation
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.
1 secondary outcome
Tremor entrainment
Time frame: During the stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Due to data protection policies
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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.
1 site in 1 country: see every site and its status.
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.