Parkinson DiseasePDMCIStimNCT04171804
Efficacy of Transcranial Direct Current Stimulation In Parkinson's Disease MCI
A study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate the efficacy of prefrontal transcranial Direct Current Stimulation (tDCS) on cognitive functions and electrophysiological measures in Parkinson's Disease Mild Cognitive Impairment (PD-MCI). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability) in accordance with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria, issued by a neurologist specializing in movement disorders;
- Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- Clinical diagnosis of PD- MCI in accordance with Level 2 Movement Disorders Society- Task Force diagnostic criteria;
- An unchanged stable and optimal regimen of dopaminergic medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study;
- Ability to provide written informed consent;
- 5 or more years of education;
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- Right-hand dominancy;
- Not taking any psychoactive medications before the previous month of the study and for the duration of the study;
- Naïve to tDCS.
Who cannot join
- Diagnosis or evidence of secondary or atypical parkinsonism;
- Patients with dementia;
- Less than 5 years of education;
- Previous history of surgical intervention for PD such as deep brain stimulation (DBS);
- Diagnosis of active major depressive disorder, psychotic disorders, bipolar disorder, alcohol use disorder and substance use disorders;
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
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- Significant hearing loss or visual impairment;
- Diagnosis of any serious or uncontrolled medical condition such as chronic obstructive pulmonary disease, congestive heart failure or renal failure;
- Skin diseases that could potentially cause irritations under electrodes
- Patients missing two consecutive protocol sessions;
- Illiteracy, deficient language or refusal to participate or being not able to follow instructions or complete study tasks;.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Prefrontal Transcranial Direct Current Stimulation On Cognitive Functions and Electrophysiological Measures In Parkinson's Disease Mild Cognitive Impairment
The aim of the present study is to investigate the efficacy of prefrontal transcranial Direct Current Stimulation (tDCS) on cognitive functions and electrophysiological measures in Parkinson's Disease Mild Cognitive Impairment (PD-MCI). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month. The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month.
Read the detailed description
Parkinson's Disease (PD) is the second most common neurodegenerative disorder. The period that apparent cognitive deficits exist without disrupting daily life activities is named as Mild Cognitive Impairment (PD-MCI). Treatments were considered to be more efficacious in PD-MCI than PD dementia as relatively less permanent changes in cortical structures occured. No approved treatments exist in PD-MCI and non-pharmacological treatments are under investigation as drugs have considerable amount of adverse effects.
Event Related Potentials (ERP) measurements have the advantages of providing direct and objective evidence of central nervous system functions, imaging of the activity of the cortical areas and being unaffected by motor deficits. ERP parameters were found to be related to cognitive functions and disrupted in PD and PD-MCI. Thus, ERP parameters were suggested to be useful in treatment efficacy assessment.
Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation method. Ameliorating effects of tDCS on cognition and ERPs were observed. Enhancing effects of tDCS on some cognitive deficits were also reported in PD.
Few studies reported the efficacy of both tDCS and physical therapy/cognitive training and none assessed the efficacy of tDCS solely, compared to a sham control group. All studies assessed the efficacy without using electrophysiological measurements that reflect central nervous system functions directly. In this project, the efficacy of tDCS will be compared to a sham tDCS group and be assessed with electrophysiological measurements for the first time.
The study is a double-blind randomized controlled trial. The sample will be consisted of twenty six participants diagnosed as having PD-MCI due to Movement Disorders Society Level 2 criteria. The participants will be assigned to active or sham groups. Then, neuropsychological test performances and ERP parameters during Oddball paradigm and Continuous Performance Test will be measured. Then, participants will be applied ten active or sham sessions of left anodal/right cathodal tDCS over the dorsolateral prefrontal cortex (DLPFC). All measurements will be repeated both immediately and 1-month after the applications.
Succinctly, the aim of this project is to assess the effect of ten sessions left anodal/right cathodal tDCS over the DLPFC on cognitive functions and electrophysiological parameters in PD-MCI.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial direct current stimulation
- Keywords
- Parkinson's Disease, Mild Cognitive Impairment, Transcranial Direct Current Stimulation, Cognitive functions, Electrophysiology, Event related potentials
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS, Direct current stimulation, transcranial electrical stimulation
Participants will receive a total of 10 stimulation sessions on 5 consecutive days (twice a day with 3-4 hours interval). During each session, 2 milliAmpers (mA) of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation |
| Sham | Sham comparator | Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in response conflict in the Stroop Test during the study period
The stroop effect consists of the semantic and the response conflict. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Minimum time difference is 0 and maximum time difference is 100 milliseconds. Lower time differences indicate better performance and higher time differences indicate worse performance.
Measured: Up to one month
Change in the verbal fluency performance during the study period
Verbal fluency is a test that measure multiple domains of cognition such as executive functions and language functions. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds, the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds. Minimum score is 0 and maximum score is 80. Lower scores indicate worse performance and higher scores indicate better performance.
Measured: Up to one month
Changes in Trail Making A Test performance during the study period
Trail Making A Test is a widely used as a quick and easy to administer measure of attention. Lower reaction times indicate better performance and higher reaction times indicate worse performance. Minimum time is 10 milliseconds and maximum time is 150 milliseconds.
Measured: Up to one month
Changes in digit span during the study period
The Digit Span test is a measure of verbal short-term/working memory. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order.
Digit span forward total score: 0-10; higher score indicate better performance, digit span backwards total score: 0-10; higher score indicate better performance
Measured: Up to one month
Changes in delayed recall performance during the study period
Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance.
Measured: Up to one month
Changes in verbal memory processes performance during the study period
The Verbal Memory Processes Test is a 15-word word-list learning test with a 40-minute delayed recall addition based on the Rey Auditory Verbal Learning Test which gives the opportunity to evaluate the processes of working memory, learning or acquiring knowledge, retention of information, and recalling.
It consists of immediate recall, learning score and a 40-min delayed recall test, followed by total recall. Higher scores indicate better performance in all indexes of the test. Minimum scores are 0 and maximum scores are 15 for immediate recall, delayed recall and total recall and 150 for learning score, respectively.
Measured: Up to one month
Changes in face recognition performance during the study period
Benton Facial Recognition Test is a common test assessing visuo-spatial functions. It was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately. Higher scores indicate better performance and lower scores indicate worse performance. Minimum score is 0 and maximum score is 54.
Measured: Up to one month
Changes in judgment of line orientation performance during the study period
A test of visuospatial judgement. The test measured the participant's ability to match the angle and orientation of lines in space. There were 30 trial in total. Correct response in a trial was awarded one point. Minimum score is 0 and maximum score is 30. Higher scores represent better performances.
Measured: Up to one month
Changes in the naming performance during the study period
The naming performance will be measured by the Boston Naming Test Short Form and Responsive Naming Test. Boston Naming Test consists of 45 pictures to be named. Minimum score is 0 and maximum score is 45. Higher scores indicate better performance and lower scores indicate worse performance. In the Responsive Naming Test, participants answer the questions such as "What do women apply to their lips?" Minimum score is 0 and maximum score is 10. Higher scores indicate better performance and lower scores indicate worse performance.
Measured: Up to one month
Changes in amplitudes (in microvolts) for parameters from the ERP tests during the study period for parameters from the ERP tests during the study period
Amplitudes (in microvolts) for the following parameters from the ERP tests will be collected as primary endpoints:N1, P3 and other common wave forms for both Two-tone auditory oddball paradigm and Continuous Performance Test ERP paradigms.
Measured: Up to one month
Changes in detection sensitivity from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period
Detection sensitivity from Signal Detection Theory (d', calculated as [zFA - zHR], where z is the inverse of the standard normal cumulative distribution, FA is the false-alarm rate [the proportion of responses made to stimuli that were not targets], and HR is the hit rate [the proportion of correct identifications of target stimuli]) during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.
Measured: Up to one month
Changes in reaction times from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period
Reaction times for the correct behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.
Measured: Up to one month
Secondary outcomes (1)
Correlation between changes in behavioral measures and changes in amplitudes of ERP components
Correlation between changes in detection sensitivity from the behavioral responses and changes in amplitudes of ERP components during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jan 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Aksu, Istanbul University
- Investigators
- Serkan Aksu, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171804
- Sponsor's protocol ID
- 2018-055
- Acronym
- PDMCIStim
- Status last verified
- Mar 2022
- First submitted
- 3 Nov 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prefrontal Transcranial Direct Current Stimulation On Cognitive Functions and Electrophysiological Measures In Parkinson's Disease Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04171804
- Acronym / sponsor ID
- PDMCIStim / 2018-055
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Mild Cognitive Impairment, Transcranial Direct Current Stimulation, Cognitive functions, Electrophysiology, Event related potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 21 Nov 2019 (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.
The aim of the present study is to investigate the efficacy of prefrontal transcranial Direct Current Stimulation (tDCS) on cognitive functions and electrophysiological measures in Parkinson's Disease Mild Cognitive Impairment (PD-MCI). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month. The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month.
Detailed description
Parkinson's Disease (PD) is the second most common neurodegenerative disorder. The period that apparent cognitive deficits exist without disrupting daily life activities is named as Mild Cognitive Impairment (PD-MCI). Treatments were considered to be more efficacious in PD-MCI than PD dementia as relatively less permanent changes in cortical structures occured. No approved treatments exist in PD-MCI and non-pharmacological treatments are under investigation as drugs have considerable amount of adverse effects.
Event Related Potentials (ERP) measurements have the advantages of providing direct and objective evidence of central nervous system functions, imaging of the activity of the cortical areas and being unaffected by motor deficits. ERP parameters were found to be related to cognitive functions and disrupted in PD and PD-MCI. Thus, ERP parameters were suggested to be useful in treatment efficacy assessment.
Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation method. Ameliorating effects of tDCS on cognition and ERPs were observed. Enhancing effects of tDCS on some cognitive deficits were also reported in PD.
Few studies reported the efficacy of both tDCS and physical therapy/cognitive training and none assessed the efficacy of tDCS solely, compared to a sham control group. All studies assessed the efficacy without using electrophysiological measurements that reflect central nervous system functions directly. In this project, the efficacy of tDCS will be compared to a sham tDCS group and be assessed with electrophysiological measurements for the first time.
The study is a double-blind randomized controlled trial. The sample will be consisted of twenty six participants diagnosed as having PD-MCI due to Movement Disorders Society Level 2 criteria. The participants will be assigned to active or sham groups. Then, neuropsychological test performances and ERP parameters during Oddball paradigm and Continuous Performance Test will be measured. Then, participants will be applied ten active or sham sessions of left anodal/right cathodal tDCS over the dorsolateral prefrontal cortex (DLPFC). All measurements will be repeated both immediately and 1-month after the applications.
Succinctly, the aim of this project is to assess the effect of ten sessions left anodal/right cathodal tDCS over the DLPFC on cognitive functions and electrophysiological parameters in PD-MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Transcranial direct current stimulationLeft anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex |
| Sham | Sham comparator | Device: Transcranial direct current stimulationSham transcranial direct current stimulation over the dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability) in accordance with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria, issued by a neurologist specializing in movement disorders;
- Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- Clinical diagnosis of PD- MCI in accordance with Level 2 Movement Disorders Society- Task Force diagnostic criteria;
- An unchanged stable and optimal regimen of dopaminergic medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study;
- Ability to provide written informed consent;
Key exclusion criteria (11 listed)
- Diagnosis or evidence of secondary or atypical parkinsonism;
- Patients with dementia;
- Less than 5 years of education;
- Previous history of surgical intervention for PD such as deep brain stimulation (DBS);
- Diagnosis of active major depressive disorder, psychotic disorders, bipolar disorder, alcohol use disorder and substance use disorders;
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 |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCS, Direct current stimulation, transcranial electrical stimulationParticipants will receive a total of 10 stimulation sessions on 5 consecutive days (twice a day with 3-4 hours interval). During each session, 2 milliAmpers (mA) of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal). | Device | Active, Sham |
Primary outcome
Changes in response conflict in the Stroop Test during the study period
Time frame: Up to one month
The stroop effect consists of the semantic and the response conflict. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Minimum time difference is 0 and maximum time difference is 100 milliseconds. Lower time differences indicate better performance and higher time differences indicate worse performance.
Change in the verbal fluency performance during the study period
Time frame: Up to one month
Verbal fluency is a test that measure multiple domains of cognition such as executive functions and language functions. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds, the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds. Minimum score is 0 and maximum score is 80. Lower scores indicate worse performance and higher scores indicate better performance.
Changes in Trail Making A Test performance during the study period
Time frame: Up to one month
Trail Making A Test is a widely used as a quick and easy to administer measure of attention. Lower reaction times indicate better performance and higher reaction times indicate worse performance. Minimum time is 10 milliseconds and maximum time is 150 milliseconds.
Changes in digit span during the study period
Time frame: Up to one month
The Digit Span test is a measure of verbal short-term/working memory. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. Digit span forward total score: 0-10; higher score indicate better performance, digit span backwards total score: 0-10; higher score indicate better performance
Changes in delayed recall performance during the study period
Time frame: Up to one month
Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance.
Changes in verbal memory processes performance during the study period
Time frame: Up to one month
The Verbal Memory Processes Test is a 15-word word-list learning test with a 40-minute delayed recall addition based on the Rey Auditory Verbal Learning Test which gives the opportunity to evaluate the processes of working memory, learning or acquiring knowledge, retention of information, and recalling. It consists of immediate recall, learning score and a 40-min delayed recall test, followed by total recall. Higher scores indicate better performance in all indexes of the test. Minimum scores are 0 and maximum scores are 15 for immediate recall, delayed recall and total recall and 150 for learning score, respectively.
Changes in face recognition performance during the study period
Time frame: Up to one month
Benton Facial Recognition Test is a common test assessing visuo-spatial functions. It was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately. Higher scores indicate better performance and lower scores indicate worse performance. Minimum score is 0 and maximum score is 54.
Changes in judgment of line orientation performance during the study period
Time frame: Up to one month
A test of visuospatial judgement. The test measured the participant's ability to match the angle and orientation of lines in space. There were 30 trial in total. Correct response in a trial was awarded one point. Minimum score is 0 and maximum score is 30. Higher scores represent better performances.
Changes in the naming performance during the study period
Time frame: Up to one month
The naming performance will be measured by the Boston Naming Test Short Form and Responsive Naming Test. Boston Naming Test consists of 45 pictures to be named. Minimum score is 0 and maximum score is 45. Higher scores indicate better performance and lower scores indicate worse performance. In the Responsive Naming Test, participants answer the questions such as "What do women apply to their lips?" Minimum score is 0 and maximum score is 10. Higher scores indicate better performance and lower scores indicate worse performance.
Changes in amplitudes (in microvolts) for parameters from the ERP tests during the study period for parameters from the ERP tests during the study period
Time frame: Up to one month
Amplitudes (in microvolts) for the following parameters from the ERP tests will be collected as primary endpoints:N1, P3 and other common wave forms for both Two-tone auditory oddball paradigm and Continuous Performance Test ERP paradigms.
Changes in detection sensitivity from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period
Time frame: Up to one month
Detection sensitivity from Signal Detection Theory (d', calculated as [zFA - zHR], where z is the inverse of the standard normal cumulative distribution, FA is the false-alarm rate [the proportion of responses made to stimuli that were not targets], and HR is the hit rate [the proportion of correct identifications of target stimuli]) during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.
Changes in reaction times from the behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms during the study period
Time frame: Up to one month
Reaction times for the correct behavioral responses during the Two-tone auditory oddball and Continuous Performance Test ERP paradigms will be measured.
1 secondary outcome
Correlation between changes in behavioral measures and changes in amplitudes of ERP components
Time frame: Up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Serkan Aksu principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in response conflict in the Stroop Test during the study period (time frame: Up to one month). The study lists 12 primary outcomes in all. 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 31 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.