Parkinson Disease (PD)PORTNCT07666477
rTMS and Olfactory Training for Parkinson's Disease
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Structured Olfactory Training in people with Parkinson Disease (PD) and Olfactory Dysfunction, run by Mustafa Baran at 1 site in Turkey (Türkiye).
Trial summary
Background: Olfactory and gustatory impairments are common clinical manifestations in patients with neurodegenerative conditions like Parkinson's disease. These chemosensory deficits significantly impact the quality of life, often preceding motor symptoms. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease (PD), Olfactory Dysfunction
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Structured Olfactory Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 21 May 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40 and 75 years.
- Confirmed diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- Confirmed olfactory dysfunction validated by the Sniffin' Sticks test at baseline (defined as a composite TDI score ≤ 30.5 for hyposmia and < 16.0 for functional anosmia).
Who cannot join
- Presence of cranial metal implants or cardiac pacemakers (absolute contraindications for rTMS).
- Pregnancy.
- Severe psychiatric disorders.
- Advanced dementia.
- History of nasal polyps or active sinusitis that could mechanically obstruct olfactory pathways.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effects of Combined Repetitive Transcranial Magnetic Stimulation and Olfactory Training on Chemosensory Recovery in Parkinson's Disease: A Randomized Controlled Trial
Background:
Olfactory and gustatory impairments are common clinical manifestations in patients with neurodegenerative conditions like Parkinson's disease. These chemosensory deficits significantly impact the quality of life, often preceding motor symptoms. Currently, there is a need for effective non-invasive interventions to improve sensory recovery.
Read more
Objective:
The primary objective of this study is to evaluate the therapeutic efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) combined with olfactory training in restoring chemosensory function. We aim to determine whether this combined approach provides superior outcomes compared to individual therapies or standard care.
Methods:
This clinical trial involves 120 patients diagnosed with Parkinson's disease. Participants will be randomized into four groups to receive either combined rTMS and olfactory training, isolated rTMS, isolated olfactory training, or a control intervention. The recovery of olfactory function will be measured using validated sensory testing tools (such as Sniffin' Sticks) and Electrogustometry (EGM) to assess neural pathway improvement.
Conclusion/Significance:
This study aims to provide evidence-based insights into non-invasive neurological rehabilitation for chemosensory dysfunction. The findings may help optimize personalized treatment protocols for patients suffering from sensory impairment, potentially enhancing their overall cognitive and sensory quality of life.
Read the detailed description
Study Design and Patient Selection:
This is a prospective, randomized, four-arm clinical study. A total of 120 patients meeting the inclusion criteria for Parkinson's disease-related chemosensory dysfunction are enrolled. Subjects are randomized using a 1:1:1:1 ratio.
Intervention Protocols:
rTMS Protocol: The intervention group receives high-frequency (10 Hz) stimulation targeted at the cortical regions associated with olfactory processing. The protocol consists of 2000 pulses per session.
Olfactory Training: Participants perform structured olfactory training utilizing standardized odorant sets, conducted twice daily over the 12-week study period.
Methodological Blinding: To ensure task compliance and methodological rigor, distilled water is utilized as a sensory blind check during testing procedures.
Measurements: Sensory assessments are focused on the lateral margins of the tongue using Electrogustometry (EGM) and standardized smell sensitivity tests. Changes in function are recorded using the Visual Analog Scale (VAS) at baseline and 12-week follow-up intervals.
Statistical Analysis:
Data is analyzed to compare the mean sensory threshold changes between the four groups. Baseline characteristics and longitudinal improvements are evaluated using ANOVA followed by post-hoc analysis to determine the statistical significance of the combined therapy versus monotherapy and control groups.
- Conditions
- Parkinson Disease (PD), Olfactory Dysfunction
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Structured Olfactory Training, Sham rTMS
- Keywords
- repetitive Transcranial Magnetic Stimulation, Parkinson's Disease, Olfactory Training, Chemosensory Dysfunction, Non-invasive Neuromodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
High-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions.
Structured Olfactory TrainingBehavioural
Daily structured olfactory training protocol using standardized odorants (twice daily).
Sham rTMSDevice
Sham stimulation delivered using an identical coil setup without neural activation.
| Study group | Role | What they receive |
|---|---|---|
| rTMS and Olfactory Training | Experimental | Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, combined with a daily structured olfactory training protocol over the 12-week study period. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Structured Olfactory Training |
| Experimental: rTMS alone | Experimental | Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, without the concurrent structured olfactory training protocol, over the 12-week study period. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Active Comparator: Olfactory Training alone | Active comparator | Participants in this group perform a structured 12-week olfactory training protocol twice daily using standardized odorants, without receiving any active rTMS stimulation. Receives: Behavioral: Structured Olfactory Training |
| Sham Comparator: Control Group | Sham comparator | Participants in this group receive sham rTMS stimulation (using a deactivated coil setup) without any structured olfactory training for the 12-week study duration. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sniffin' Sticks TDI Score from Baseline to Week 12
The Sniffin' Sticks test evaluates olfactory function through Threshold, Discrimination, and Identification (TDI) scores. The primary endpoint is the mean change in the composite TDI score (range 1-48) from the start of the study (Baseline) to the end of the intervention (Week 12).
Measured: Baseline and 12 weeks.
Secondary outcomes (3)
Change in Sniffin' Sticks Odor Threshold Score from Baseline to Week 12
The Sniffin' Sticks Odor Threshold Subtest evaluates olfactory sensory thresholds. Scores on this subtest range from a minimum of 1 to a maximum of 16. Higher scores indicate better olfactory function (a more sensitive odor threshold). The endpoint is the mean change in the odor threshold score from the start of the study (Baseline) to the end of the intervention (Week 12).
Measured: Baseline and 12 weeks.
Change in Sniffin' Sticks Odor Discrimination Score from Baseline to Week 12
The Sniffin' Sticks Odor Discrimination Subtest evaluates the ability to differentiate between distinct odorants. Scores on this subtest range from a minimum of 1 to a maximum of 16. Higher scores indicate better olfactory function. The endpoint is the mean change in the odor discrimination score from the start of the study (Baseline) to the end of the intervention (Week 12).
Measured: Baseline and 12 weeks.
Change in Sniffin' Sticks Odor Identification Score from Baseline to Week 12
The Sniffin' Sticks Odor Identification Subtest evaluates the cognitive ability to identify specific odorants. Scores on this subtest range from a minimum of 1 to a maximum of 16. Higher scores indicate better olfactory function. The endpoint is the mean change in the odor identification score from the start of the study (Baseline) to the end of the intervention (Week 12).
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start2 Jan 2026
- Primary completion15 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- 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
- Model description
- Participants are randomized into four distinct groups (1:1:1:1 ratio) to receive their respective interventions simultaneously. Each participant remains within their assigned group throughout the entire 12-week study period, with no crossover between intervention protocols, ensuring independent assessment of the therapeutic effects for each group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Baran
- Sponsor type
- University, hospital or other
- Collaborators
- Batman University
- Responsible party
- Sponsor-investigator, Mustafa Baran, Batman University
- Investigators
- Mustafa BARAN, PhD, Principal investigator, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666477
- Sponsor's protocol ID
- 2025/02-04
- Acronym
- PORT
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.
PubMed 10867835Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.
PubMed 19235739Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Combined Repetitive Transcranial Magnetic Stimulation and Olfactory Training on Chemosensory Recovery in Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07666477
- Acronym / sponsor ID
- PORT / 2025/02-04
- Conditions
- Parkinson Disease (PD), Olfactory Dysfunction
- Keywords
- repetitive Transcranial Magnetic Stimulation, Parkinson's Disease, Olfactory Training, Chemosensory Dysfunction, Non-invasive Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mustafa BaranUniversity, hospital or other
- Collaborators
- Batman University
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 24 Jun 2026 (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.
Background:
Olfactory and gustatory impairments are common clinical manifestations in patients with neurodegenerative conditions like Parkinson's disease. These chemosensory deficits significantly impact the quality of life, often preceding motor symptoms. Currently, there is a need for effective non-invasive interventions to improve sensory recovery.
Objective:
The primary objective of this study is to evaluate the therapeutic efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) combined with olfactory training in restoring chemosensory function. We aim to determine whether this combined approach provides superior outcomes compared to individual therapies or standard care.
Methods:
This clinical trial involves 120 patients diagnosed with Parkinson's disease. Participants will be randomized into four groups to receive either combined rTMS and olfactory training, isolated rTMS, isolated olfactory training, or a control intervention. The recovery of olfactory function will be measured using validated sensory testing tools (such as Sniffin' Sticks) and Electrogustometry (EGM) to assess neural pathway improvement.
Conclusion/Significance:
This study aims to provide evidence-based insights into non-invasive neurological rehabilitation for chemosensory dysfunction. The findings may help optimize personalized treatment protocols for patients suffering from sensory impairment, potentially enhancing their overall cognitive and sensory quality of life.
Detailed description
Study Design and Patient Selection:
This is a prospective, randomized, four-arm clinical study. A total of 120 patients meeting the inclusion criteria for Parkinson's disease-related chemosensory dysfunction are enrolled. Subjects are randomized using a 1:1:1:1 ratio.
Intervention Protocols:
rTMS Protocol: The intervention group receives high-frequency (10 Hz) stimulation targeted at the cortical regions associated with olfactory processing. The protocol consists of 2000 pulses per session.
Olfactory Training: Participants perform structured olfactory training utilizing standardized odorant sets, conducted twice daily over the 12-week study period.
Methodological Blinding: To ensure task compliance and methodological rigor, distilled water is utilized as a sensory blind check during testing procedures.
Measurements: Sensory assessments are focused on the lateral margins of the tongue using Electrogustometry (EGM) and standardized smell sensitivity tests. Changes in function are recorded using the Visual Analog Scale (VAS) at baseline and 12-week follow-up intervals.
Statistical Analysis:
Data is analyzed to compare the mean sensory threshold changes between the four groups. Baseline characteristics and longitudinal improvements are evaluated using ANOVA followed by post-hoc analysis to determine the statistical significance of the combined therapy versus monotherapy and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomized into four distinct groups (1:1:1:1 ratio) to receive their respective interventions simultaneously. Each participant remains within their assigned group throughout the entire 12-week study period, with no crossover between intervention protocols, ensuring independent assessment of the therapeutic effects for each group.
| Arm | Type | Receives |
|---|---|---|
| rTMS and Olfactory Training | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Structured Olfactory TrainingParticipants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, combined with a daily structured olfactory training protocol over the 12-week study period. |
| Experimental: rTMS alone | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants in this group receive high-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions, without the concurrent structured olfactory training protocol, over the 12-week study period. |
| Active Comparator: Olfactory Training alone | Active comparator | Behavioral: Structured Olfactory TrainingParticipants in this group perform a structured 12-week olfactory training protocol twice daily using standardized odorants, without receiving any active rTMS stimulation. |
| Sham Comparator: Control Group | Sham comparator | Device: Sham rTMSParticipants in this group receive sham rTMS stimulation (using a deactivated coil setup) without any structured olfactory training for the 12-week study duration. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 40 and 75 years.
- Confirmed diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- Confirmed olfactory dysfunction validated by the Sniffin' Sticks test at baseline (defined as a composite TDI score ≤ 30.5 for hyposmia and < 16.0 for functional anosmia).
Key exclusion criteria (5 listed)
- Presence of cranial metal implants or cardiac pacemakers (absolute contraindications for rTMS).
- Pregnancy.
- Severe psychiatric disorders.
- Advanced dementia.
- History of nasal polyps or active sinusitis that could mechanically obstruct olfactory pathways.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)High-frequency (10 Hz) rTMS stimulation (2000 pulses per session) targeted at cortical olfactory regions. | Device | Experimental: rTMS alone, rTMS and Olfactory Training |
| Structured Olfactory TrainingDaily structured olfactory training protocol using standardized odorants (twice daily). | Behavioural | Active Comparator: Olfactory Training alone, rTMS and Olfactory Training |
| Sham rTMSSham stimulation delivered using an identical coil setup without neural activation. | Device | Sham Comparator: Control Group |
Primary outcome
Change in Sniffin' Sticks TDI Score from Baseline to Week 12
Time frame: Baseline and 12 weeks.
The Sniffin' Sticks test evaluates olfactory function through Threshold, Discrimination, and Identification (TDI) scores. The primary endpoint is the mean change in the composite TDI score (range 1-48) from the start of the study (Baseline) to the end of the intervention (Week 12).
3 secondary outcomes
Change in Sniffin' Sticks Odor Threshold Score from Baseline to Week 12
Time frame: Baseline and 12 weeks.
Change in Sniffin' Sticks Odor Discrimination Score from Baseline to Week 12
Time frame: Baseline and 12 weeks.
Change in Sniffin' Sticks Odor Identification Score from Baseline to Week 12
Time frame: Baseline and 12 weeks.
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 26 Jun 2026.
- Background: PubMed 10867835Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 19235739Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.
- Background: PubMed 26474316Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Mustafa BARAN, PhD principal investigator
Batman 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 Repetitive Transcranial Magnetic Stimulation (rTMS) and Structured Olfactory Training in people with Parkinson Disease (PD) and Olfactory Dysfunction, run by Mustafa Baran 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 3 inclusion and 5 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 26 Jun 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 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?
Change in Sniffin' Sticks TDI Score from Baseline to Week 12 (time frame: Baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07666477, which also lists 4 linked publications.
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 26 Jun 2026.