The effects of gamma tACS on cortical excitability and movement in Parkinson patients compared to healthy controls
Organizational Data
- DRKS-ID:
- DRKS00024035
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-04-06
- Last update in DRKS:
- 2023-02-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
park GammatACS
URL of the study
No Entry
Brief summary in lay language
The purpose of the study is to evaluate the effects of transcranial alternating current stimulation (tACS) on brain waves, movement and the excitability of the motor cortex. The motor cortex is a specific area of the brain that is important in the voluntary control of muscle movement. Recent research showed that tACS can modulate the excitability of the motor cortex and can also influence brain waves in healthy participants. Brain waves are rhythmic electric firings of nerve cells. They are associated with different conditions, for instance, alpha waves are associated with a relaxed state and gamma waves are associated with movement planning and concentration. tACS can be administered at the frequency of certain brain waves. In the present study, we want to evaluate the effects of tACS in the frequency of gamma waves on movement and motor cortex excitability in participants with Parkinson´s Disease as well as in healthy participants to be able to compare the results.
Brief summary in scientific language
Gamma frequency oscillations (30-90 Hz) are assumed to play a role in the change of movement as well as in altered cortical excitability. These oscillations may be of clinical importance in Parkinson´s Disease patients (PD) as they exhibit lower gamma frequency oscillations; the lack thereof might be significant in the pathophysiology of the disorder. Furthermore, a change of movement in these patients contributes to an increase in bradykinesia, thus a lack of gamma oscillations might be of clinical importance due to its assumed role in movement planning. In literature so far, a modulation of neural oscillations amongst others could be achieved by transcranial alternating current stimulation (tACS). However, there is a lack of research investigating gamma frequency modulation in patients suffering from Parkinson’s Disease. Therefore we aim to shed light on the role of gamma tACS on cortical excitability and movement in PD patients, compared to controls. This study will be conducted in a repeated-measures, within-subjects design, in which participants will undergo 2 different sessions. Individual peak gamma frequencies will be determined per subject via EEG measurements. The identified peak frequencies will be used for stimulation in subsequent sessions. In the first and second session, participants will either receive tACS intervention or sham stimulation. Participants will be randomly assigned to the first and second session.
Health condition or problem studied
- ICD10:
- G20 - Parkinson disease
- ICD10:
- G20.1
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- This study evaluates the effect of gamma tACS on movement and cortical excitability in Parkinson patients and healthy participants. Both groups undergo 2 sessions: in one session they will receive 20 min. of gamma tACS, whereas in the other session they will receive sham stimulation. Which session the participant will first be enrolled in is randomized. Arm 1= Parkinson patients (gamma tACS and Sham)
- Arm 2:
- Arm 2 = healthy participants (gamma tACS and sham)
Endpoints
- Primary outcome:
- The endpoint is the improvement of motor function after gamma tACS. Improve motor function will be assessed by the UPDRS, and changes in results in the Nine-hole- peg test and alternating finger tapping task.
- Secondary outcome:
- The secondary endpoint is the change in reaction time after the execution of a motor task in the course of the experiment.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Double blind
- Blinding:
- Yes
- Assignment:
- Factorial
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Oldenburg
Recruitment period and number of participants
- Planned study start date:
- 2021-04-07
- Actual study start date:
- 2021-04-22
- Planned study completion date:
- 2023-04-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 24
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 50 Years
- Maximum Age:
- 75 Years
- Additional Inclusion Criteria:
- Parkinson Patients: a) diagnosed PD in a mild to moderate stage, equivalent UPDRS (part III) < 35 b) Right-handedness c) Age 50 -75 years d) Fluency in German or English. Healthy Subjects are recruited based on : b), c) and d)
Exclusion Criteria
For healthy subjects and PD patients: a) Implanted neurostimulators, cochlear implants or general implanted metal in the cranium b) Psychiatric disorders (i.e. schizophrenia, severe dementia) c) Epilepsy d) Use of contraindicated medication (i.e. neuroleptics, opioids) e) Coffee or alcohol consumption prior to the experiment
Addresses
Primary Sponsor
- Address:
- Carl von Ossietzky Universität Oldenburg Fakultät VI - Medizin und Gesundheitswissenschaften Department für HumanmedizinPostfach 250326111 OldenburgGermany
- Telephone:
- +49 (0)441 798-4657
- Fax:
- +49 (0)441 236 650
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/neurologie
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinik für Neurologie, Carl von Ossietzky Universität Oldenburg Fakultät VI- Medizin und Gesundheitswissenschaften Department für HumanmedizinProf. Dr. med. Karsten WittPostfach 250326121 OldenburgGermany
- Telephone:
- +49 (0)441 798-4657
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/neurologie
Contact for Public Queries
- Address:
- Sekretariat der Universitätsklinik für NeurologieCarl von Ossietzky Universität OldenburgMartina BantelHeiligengeisthöfe 426121 OldenburgGermany
- Telephone:
- +49 (0)441 798-4657
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/neurologie
Principal Investigator
- Address:
- Universitätsklinik für Neurologie, Carl von Ossietzky Universität Oldenburg Fakultät VI- Medizin und Gesundheitswissenschaften Department für HumanmedizinProf. Dr. med. Karsten WittPostfach 250326121 OldenburgGermany
- Telephone:
- +49 (0)441 798-4657
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/neurologie
Other principal investigator
- Address:
- Carl von Ossietzy Universität Oldenburg Fakultät VI - Medizin und Gesundheitswissenschaften Abt. Allgemeine Psychologie Dep. für PsychologieProf. Dr. Christoph HerrmannAmmerländer Heerstr. 114-11826129 OldenburgGermany
- Telephone:
- +49 (0)441 798–3815
- Fax:
- +49 (0)441 798–3865
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/allgemeine-psychologie
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Carl von Ossietzky Universität OldenburgFakultät VI - Medizin und GesundheitswissenschaftenDepartment für HumanmedizinPostfach 250326111 OldenburgGermany
- Telephone:
- +49 (0)441 798-4657
- Fax:
- +49 (0)441 236 650
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/neurologie
Ethics Committee
Address Ethics Committee
- Address:
- Geschäftsstelle der medizinischen Ethikkommission, Fakultät VI Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg, Gebäude V04 (Raum 1-137)Ammerländer Heerstraße 14026129 OldenburgGermany
- Telephone:
- +49-441-7983109
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-02-16
- Ethics committee number:
- 2018-117
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-04-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Data will be shared upon request
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry