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

NCT06993571 | Recruiting

• 1 other identifier: Cereb_tACS_PD_TR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (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.

  During the stimulation

Secondary Outcomes (1)

• Tremor entrainment

  During the stimulation

Study Arms (3)

Active-tACS

EXPERIMENTAL

Patients receive an active tACS stimulation with 2-4 mA amplitude

Device: Active-tACS

Sham-tACS

SHAM COMPARATOR

Patients receive a tACS stimulation with 0 mA amplitude

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

Device: Unlocked-tACS

Interventions

Active-tACS DEVICE

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.

Active-tACS

Sham-tACS DEVICE

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.

Sham-tACS

Unlocked-tACS DEVICE

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.

Unlocked-tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simone Zittel, Dr. med.

CONTACT

+49 40 7410 53770; s.zittel-dirks@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will receive active, sham, and control stimulation in a randomized manner.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)