BradykinesiaADAPT-BKNCT07397377
prTMS as an Intervention for Bradykinesia in Parkinson's Disease
A study testing Active patterned repetitive transcranial magnetic stimulation (prTMS) in people with Bradykinesia and Parkinson Disease, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
Trial summary
This study investigates the use of patterned repetitive transcranial magnetic stimulation (prTMS) as an intervention for bradykinesia in Parkinson's Disease (PD). More specifically, the study aims to determine whether prTMS over the supplementary motor area (SMA) can reduce severity of bradykinesia in PD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bradykinesia, Parkinson Disease
- What is being tested?
- Active patterned repetitive transcranial magnetic stimulation (prTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Dec 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age. Clinically established or probable Parkinson's Disease (PD), according to the Movement Disorder Society.
- Clinical Diagnostic Criteria for PD. Stable antiparkinsonian medicine for at least four weeks. Signed informed consent.
Who cannot join
- Psychiatric disorders. Current use of antipsychotic medication, Donepezil, or GABAergic agents (e.g., pregabalin, gabapentin).
- Frequent benzodiazepine or opioid use defined as more than once per week on a regular basis.
- History of neurological disease other than PD. Past or present mental illness. History of epilepsy/conditions associated with increased risk of seizure induction through transcranial magnetic stimulation (TMS).
- Close relatives suffering from epilepsy/conditions associated with increased risk of seizures.
- Contraindications for magnetic resonance imaging (MRI) Contraindications for TMS Female participants of childbearing age must not be pregnant and must use contraception during the trial.
- Refuse to be informed about new health-related information and accidental health-related findings that might appear through participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
DRCMR
Hvidovre, 2650
Hartwig Siebner, Head of Research, Prof., DMSc, +45 38 62 65 41, hartwig@drcmr.dk
About this study
Official title: Enhancing rTMS Effects Through a State-Dependent Approach - An Intervention for Bradykinesia in Parkinson's Disease
This study investigates the use of patterned repetitive transcranial magnetic stimulation (prTMS) as an intervention for bradykinesia in Parkinson's Disease (PD). More specifically, the study aims to determine whether prTMS over the supplementary motor area (SMA) can reduce severity of bradykinesia in PD patients. This approach may open for more targeted and effective treatment of bradykinesia in PD.
Read the detailed description
Bradykinesia is one of the core symptoms of Parkinson's Disease (PD) and has multiple facets. Movements become slower and decrease in amplitude. Speed and amplitude of movements decline gradually during repetitive movements, referred to as sequence effect. Spontaneous movements are also reduced, and movement initiation is impaired. These symptoms arise from dysfunction within the brain's motor network, particularly involving the basal ganglia-thalamo-cortical loop. The consequences of bradykinesia are far-reaching, severely affecting the patient's daily life and well-being.
Bradykinesia is primarily treated successfully with pharmacologically dopamine precursor levodopa and/or dopamine agonists. However, not all facets of bradykinesia response to dopamine such as the sequence effect and in addition as disease progresses adverse side effects emerge from medication such as dyskinesia which is involuntary choreiform or dystonic movements. These adverse effects require advanced therapies such as invasive treatment with deep brain stimulation (DBS). However, DBS is highly invasive, expensive, and may come with serious side effects.
Transcranial magnetic stimulation (TMS) has emerged as a promising non-invasive and cost-effective intervention for alleviating bradykinesia. In particular, patterned repetitive TMS (prTMS) over several brain regions including the supplementary motor area (SMA) has shown potential in modulating dysfunctional neural circuits and improving motor symptoms in patients with PD. Recent evidence suggests that the efficacy of prTMS may be enhanced by aligning stimulation with specific brain states, as the brain is most responsive to plasticity-inducing protocols right before a movement.
The current study aims to develop and validate a novel burst-based prTMS protocol called quadri-pulse stimulation (QPS), which consist of high-frequency burst with four pulses in each burst. An excitatory 200 hertz (Hz) QPS protocol has already shown to induce long-lasting plasticity changes and by incorporating the state of the brain the study aim to further enhance the effect of this QPS protocol.
Through a cross-over study design the study will apply active QPS right before a movement, active QPS between movement and sham condition before a movement in patients with PD to determine which produces a meaningful reduction in bradykinesia severity measured by Movement Disorder Society Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS-III) and Modified Bradykinesia Rating Scale (MBRS).
- Conditions
- Bradykinesia, Parkinson Disease
- Being tested
- Active patterned repetitive transcranial magnetic stimulation (prTMS), Sham patterned repetitive transcranial magnetic stimulation (prTMS)
- Keywords
- Bradykinesia, Basal Ganglia Diseases, Parkinson's Disease, Central Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases, SMA, TMS
- Medical subject headings
- Hypokinesia, Parkinson Disease, Basal Ganglia Diseases, Central Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active patterned repetitive transcranial magnetic stimulation (prTMS)Device
Transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot using active side of MagVenture Cool-B65 coil
Sham patterned repetitive transcranial magnetic stimulation (prTMS)Device
Sham transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot, flipping the active side of the MagVenture Cool-B65 coil.
| Study group | Role | What they receive |
|---|---|---|
| Active patterned repetitive transcranial magnetic stimulation (prTMS) before a movement | Active comparator | Real stimulation with four pulses at the frequency of 200 Hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the active side of the coil for 30 min. Every burst will be given 100 milliseconds (ms) before a movement. Receives: Device: Active patterned repetitive transcranial magnetic stimulation (prTMS) |
| Active patterned repetitive transcranial magnetic stimulation (prTMS) between a movement | Experimental | Real stimulation with four pulses at the frequency of 200 hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the active side of the coil for 30 min. Every burst will be given between movements. Receives: Device: Active patterned repetitive transcranial magnetic stimulation (prTMS) |
| Sham patterned repetitive transcranial magnetic stimulation (prTMS) before a movement | Sham comparator | Sham stimulation with four pulses at the frequency of 200 hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the non-active side of the coil for 30 min. Every burst will be 100 milliseconds (ms) before a movement. Receives: Device: Sham patterned repetitive transcranial magnetic stimulation (prTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (3.4-3.8) (MDS-UPDRS-III)
Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in active stimulation compared to sham stimulation. More specifically the bradykinesia scores in 3.4 to 3.8. The total scores range from 0 (good health) to 132 (poor health).
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Modified Bradykinesia Rating Scale (MBRS)
Measure the changes of scores of MBRS in active stimulation compared to sham stimulation. A score from 0 (normale) to 4 (barely perform the excercise) will be given for speed, amplitude and rhythmed in differnet task relating the bradykinesia,
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Secondary outcomes (4)
Transcranial evoked potentials (TEPs)
Change in cortical excitability pre-post stimulation over the SMA
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Change from pre- to post patterned repetitive transcranial stimulation (prTMS) in resting-state EEG spectral power in predefined frequency bands
Spectral power will be quantified in a priori defined frequency bands (e.g., delta, theta, alpha, beta).
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Hand Grip Test Battery
By using grip force devices we will measure:
- Single grip force both cued and non-cued to test rate of force development and yank
- Repetitive grip to test sequence effect and fatiguability
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Motor Evoked Potentials (MEPs)
Change in cortical excitability pre-post stimulation measured bilateral from the first dorsal interosseous and tibialis anterior
Measured: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start16 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradykinesiaStudies 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
- Crossover
- Model description
- The study has a double-blinded crossover design . The research participant will, in three separate stimulation sessions, receive either active patterned repetitive transcranial magnetic stimulation (prTMS) before a movement, active prTMS between movements or sham prTMS before a movement. The sessions order will be randomized between research participants. The research participants will be blinded to which treatment they receive at any session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hartwig R. Siebner, Danish Research Centre for Magnetic Resonance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397377
- Sponsor's protocol ID
- 2500445
- Acronym
- ADAPT-BK
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of anonymized data
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing rTMS Effects Through a State-Dependent Approach - An Intervention for Bradykinesia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07397377
- Acronym / sponsor ID
- ADAPT-BK / 2500445
- Conditions
- Bradykinesia, Parkinson Disease
- Keywords
- Bradykinesia, Basal Ganglia Diseases, Parkinson's Disease, Central Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases, SMA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Danish Research Centre for Magnetic ResonanceUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Feb 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.
This study investigates the use of patterned repetitive transcranial magnetic stimulation (prTMS) as an intervention for bradykinesia in Parkinson's Disease (PD). More specifically, the study aims to determine whether prTMS over the supplementary motor area (SMA) can reduce severity of bradykinesia in PD patients. This approach may open for more targeted and effective treatment of bradykinesia in PD.
Detailed description
Bradykinesia is one of the core symptoms of Parkinson's Disease (PD) and has multiple facets. Movements become slower and decrease in amplitude. Speed and amplitude of movements decline gradually during repetitive movements, referred to as sequence effect. Spontaneous movements are also reduced, and movement initiation is impaired. These symptoms arise from dysfunction within the brain's motor network, particularly involving the basal ganglia-thalamo-cortical loop. The consequences of bradykinesia are far-reaching, severely affecting the patient's daily life and well-being.
Bradykinesia is primarily treated successfully with pharmacologically dopamine precursor levodopa and/or dopamine agonists. However, not all facets of bradykinesia response to dopamine such as the sequence effect and in addition as disease progresses adverse side effects emerge from medication such as dyskinesia which is involuntary choreiform or dystonic movements. These adverse effects require advanced therapies such as invasive treatment with deep brain stimulation (DBS). However, DBS is highly invasive, expensive, and may come with serious side effects.
Transcranial magnetic stimulation (TMS) has emerged as a promising non-invasive and cost-effective intervention for alleviating bradykinesia. In particular, patterned repetitive TMS (prTMS) over several brain regions including the supplementary motor area (SMA) has shown potential in modulating dysfunctional neural circuits and improving motor symptoms in patients with PD. Recent evidence suggests that the efficacy of prTMS may be enhanced by aligning stimulation with specific brain states, as the brain is most responsive to plasticity-inducing protocols right before a movement.
The current study aims to develop and validate a novel burst-based prTMS protocol called quadri-pulse stimulation (QPS), which consist of high-frequency burst with four pulses in each burst. An excitatory 200 hertz (Hz) QPS protocol has already shown to induce long-lasting plasticity changes and by incorporating the state of the brain the study aim to further enhance the effect of this QPS protocol.
Through a cross-over study design the study will apply active QPS right before a movement, active QPS between movement and sham condition before a movement in patients with PD to determine which produces a meaningful reduction in bradykinesia severity measured by Movement Disorder Society Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS-III) and Modified Bradykinesia Rating Scale (MBRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study has a double-blinded crossover design . The research participant will, in three separate stimulation sessions, receive either active patterned repetitive transcranial magnetic stimulation (prTMS) before a movement, active prTMS between movements or sham prTMS before a movement. The sessions order will be randomized between research participants. The research participants will be blinded to which treatment they receive at any session.
| Arm | Type | Receives |
|---|---|---|
| Active patterned repetitive transcranial magnetic stimulation (prTMS) before a movement | Active comparator | Device: Active patterned repetitive transcranial magnetic stimulation (prTMS)Real stimulation with four pulses at the frequency of 200 Hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the active side of the coil for 30 min. Every burst will be given 100 milliseconds (ms) before a movement. |
| Active patterned repetitive transcranial magnetic stimulation (prTMS) between a movement | Experimental | Device: Active patterned repetitive transcranial magnetic stimulation (prTMS)Real stimulation with four pulses at the frequency of 200 hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the active side of the coil for 30 min. Every burst will be given between movements. |
| Sham patterned repetitive transcranial magnetic stimulation (prTMS) before a movement | Sham comparator | Device: Sham patterned repetitive transcranial magnetic stimulation (prTMS)Sham stimulation with four pulses at the frequency of 200 hertz (Hz) repeating a 0.2Hz will be delivered on the supplementary motor area (SMA) using the non-active side of the coil for 30 min. Every burst will be 100 milliseconds (ms) before a movement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years of age. Clinically established or probable Parkinson's Disease (PD), according to the Movement Disorder Society.
- Clinical Diagnostic Criteria for PD. Stable antiparkinsonian medicine for at least four weeks. Signed informed consent.
Key exclusion criteria (6 listed)
- Psychiatric disorders. Current use of antipsychotic medication, Donepezil, or GABAergic agents (e.g., pregabalin, gabapentin).
- Frequent benzodiazepine or opioid use defined as more than once per week on a regular basis.
- History of neurological disease other than PD. Past or present mental illness. History of epilepsy/conditions associated with increased risk of seizure induction through transcranial magnetic stimulation (TMS).
- Close relatives suffering from epilepsy/conditions associated with increased risk of seizures.
- Contraindications for magnetic resonance imaging (MRI) Contraindications for TMS Female participants of childbearing age must not be pregnant and must use contraception during the trial.
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 |
|---|---|---|
| Active patterned repetitive transcranial magnetic stimulation (prTMS)Transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot using active side of MagVenture Cool-B65 coil | Device | Active patterned repetitive transcranial magnetic stimulation (prTMS) before a movement, Active patterned repetitive transcranial magnetic stimulation (prTMS) between a movement |
| Sham patterned repetitive transcranial magnetic stimulation (prTMS)Sham transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot, flipping the active side of the MagVenture Cool-B65 coil. | Device | Sham patterned repetitive transcranial magnetic stimulation (prTMS) before a movement |
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (3.4-3.8) (MDS-UPDRS-III)
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in active stimulation compared to sham stimulation. More specifically the bradykinesia scores in 3.4 to 3.8. The total scores range from 0 (good health) to 132 (poor health).
Modified Bradykinesia Rating Scale (MBRS)
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Measure the changes of scores of MBRS in active stimulation compared to sham stimulation. A score from 0 (normale) to 4 (barely perform the excercise) will be given for speed, amplitude and rhythmed in differnet task relating the bradykinesia,
4 secondary outcomes
Transcranial evoked potentials (TEPs)
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Change from pre- to post patterned repetitive transcranial stimulation (prTMS) in resting-state EEG spectral power in predefined frequency bands
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Hand Grip Test Battery
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Motor Evoked Potentials (MEPs)
Time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Sharing of anonymized data
Related trials for Bradykinesia
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Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations
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Effects of a Multicomponent Protocol With Emphasis on Muscle Power Training on Bradykinesia in Individuals With Parkinson's Disease
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Enrolling by invitation
Deep Brain Stimulation in Parkinson's Disease: Motor and Functional Outcomes
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Enrolling by invitation
Effects of Stimulation Patterns of Deep Brain Stimulation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active patterned repetitive transcranial magnetic stimulation (prTMS) in people with Bradykinesia and Parkinson Disease, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Feb 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann-Charlot Rughaven, M.Sc. (+4521123531, ann-charlot.rughaven@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (3.4-3.8) (MDS-UPDRS-III) (time frame: Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)). The study lists 2 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 9 Feb 2026.