At Home Transcranial Alternating Current Stimulation in Parkinson’s Disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037719

Enrollment

Registered

2025-11-25

Start date

2026-02-06

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

G20.90

Interventions

Group 1: Gamma transcranial alternating current stimulation (tACS) Participants receive daily gamma-frequency tACS over the primary motor cortex (M1), administered at home using a portable stimulatio

Eligibility

Sex/Gender

All

Age

45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Normal or corrected normal vision, Diagnosis of idiopathic Parkinson's disease according to MDS criteria, study companion (caregiver) who can assist the participant with home stimulation.

Exclusion criteria

Exclusion criteria: Previous neurological or psychiatric conditions (except Parkinson's disease), use of centrally acting medications (except Parkinson's medication), non-removable metallic objects in/on the body, implanted neurostimulators, epilepsy in personal medical history or immediate family, dementia, MoCA < 21 points, Pregnancy

Design outcomes

Primary

Measure	Time frame
Feasibility (error-free operation by participants and accompanying persons/caregivers) and Adherence to the Home-tACS protocol WHAT (Definition): – Feasibility (error-free operation): A participant is considered to operate the device “error-free” if both the participant and the accompanying caregiver are able to perform the tACS sessions according to protocol, i.e., correct electrode placement, adherence to prescribed stimulation parameters, correct start and stop of the session, and use of safety procedures, without protocol-relevant errors. Steps to be evaluated (per session): 1. Filling the electrodes with saline 2. Placing the headset 3. Entering the 5-digit code into the stimulation device 4. Starting the session 5. Ending the session 6. Removing and cleaning the electrodes Feasibility rating scale: 2 = fully independent All 6 steps were completed without remote support from the study team (all steps = “independent”). 1 = partial support required The participant/caregiver performed the majority of steps independently (=4 of 6), but one to four steps required brief remote support (phone/video). 0 = full support required Five of the six steps were performed with remote support. – Adherence: Percentage of correctly completed tACS sessions relative to the number of planned sessions for each participant (formula: completed correct sessions ÷ planned sessions × 100). WHEN (Time points of assessment): -During training/baseline (Visit 1): Initial supervised assessment of device handling. -Daily during the intervention phase (home phase): Continuous documentation of errors and adherence for each session. -Intermediate check: Remote/video check or telephone assessment, with repetition of the checklist if required. -Post-intervention (Visit 2): Summary evaluation of feasibility and calculation of adherence across the full intervention period; collection of subjective assessments from participants and caregivers. HOW (Measurement methods / instruments): -Objective de	—

Measure

Time frame

Feasibility (error-free operation by participants and accompanying persons/caregivers) and Adherence to the Home-tACS protocol WHAT (Definition): – Feasibility (error-free operation): A participant is considered to operate the device “error-free” if both the participant and the accompanying caregiver are able to perform the tACS sessions according to protocol, i.e., correct electrode placement, adherence to prescribed stimulation parameters, correct start and stop of the session, and use of safety procedures, without protocol-relevant errors. Steps to be evaluated (per session): 1. Filling the electrodes with saline 2. Placing the headset 3. Entering the 5-digit code into the stimulation device 4. Starting the session 5. Ending the session 6. Removing and cleaning the electrodes Feasibility rating scale: 2 = fully independent All 6 steps were completed without remote support from the study team (all steps = “independent”). 1 = partial support required The participant/caregiver performed the majority of steps independently (=4 of 6), but one to four steps required brief remote support (phone/video). 0 = full support required Five of the six steps were performed with remote support. – Adherence: Percentage of correctly completed tACS sessions relative to the number of planned sessions for each participant (formula: completed correct sessions ÷ planned sessions × 100). WHEN (Time points of assessment): -During training/baseline (Visit 1): Initial supervised assessment of device handling. -Daily during the intervention phase (home phase): Continuous documentation of errors and adherence for each session. -Intermediate check: Remote/video check or telephone assessment, with repetition of the checklist if required. -Post-intervention (Visit 2): Summary evaluation of feasibility and calculation of adherence across the full intervention period; collection of subjective assessments from participants and caregivers. HOW (Measurement methods / instruments): -Objective de

—

Secondary

Measure	Time frame
Side Effects / Adverse Events, Behavioral endpoint – alternating finger tapping task (aFTT), neurophysiological endpoint: gamma band power over M1, measured with EEG + transcranial magnetic stimulation (TMS)-based markers, Unified Parkinson’s Disease Rating Scale Teil III (UPDRS-III), Jebsen–Taylor Hand Function Test (JHFT), Functional Gait Assessment (FGA), Beck Depression Inventory (BDI-II), Parkinson’s Disease Questionnaire-39 (PDQ-39), Montreal Cognitive Assessment (MoCA), Test of Attentional Performance (TAP-M)	—

Measure

Time frame

Side Effects / Adverse Events, Behavioral endpoint – alternating finger tapping task (aFTT), neurophysiological endpoint: gamma band power over M1, measured with EEG + transcranial magnetic stimulation (TMS)-based markers, Unified Parkinson’s Disease Rating Scale Teil III (UPDRS-III), Jebsen–Taylor Hand Function Test (JHFT), Functional Gait Assessment (FGA), Beck Depression Inventory (BDI-II), Parkinson’s Disease Questionnaire-39 (PDQ-39), Montreal Cognitive Assessment (MoCA), Test of Attentional Performance (TAP-M)

—

Countries

Germany

Contacts

Public ContactChristoph Herrmann

Carl von Ossietzky Universität Oldenburg

christoph.herrmann@uni-oldenburg.de+49 (0)441 798–3815

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026