prTMS as an Intervention for Bradykinesia in Parkinson's Disease

NCT07397377 | Recruiting

• 1 other identifier: 2500445
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. This approach may open for more targeted and effective treatment of bradykinesia in PD.

Conditions

Bradykinesia; Parkinson Disease

Keywords

Bradykinesia; Basal Ganglia Diseases; Parkinson's Disease; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; SMA; TMS

Outcome Measures

Primary Outcomes (2)

• 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).

  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,

  Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)

Secondary Outcomes (4)

• Transcranial evoked potentials (TEPs)

  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

  Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)

• Hand Grip Test Battery

  Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)

• Motor Evoked Potentials (MEPs)

  Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)

Other Outcomes (6)

• Transcranial Magnetic Stimulation Adverse Events and Associated Sensations Questionnaire (TMSens_Q)

  Immediately after the patterned repetitive transcranial magnetic stimulation (prTMS) intervention

• Non-Motor Symptoms Scale for Parkinson's Disease (NMSS)

  Baseline, 4-8 weeks after inclusion

• CANTAB battery

  Baseline, 4-8 weeks after inclusion

Study Arms (3)

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.

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.

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.

Device: Sham patterned repetitive transcranial magnetic stimulation (prTMS)

Interventions

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

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) DEVICE

Sham transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot, flipping the active side of the MagVenture Cool-B65 coil.

Sham patterned repetitive transcranial magnetic stimulation (prTMS) before a movement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Research Centre for Magnetic Resonance: lead

Study Sites (1)

DRCMR

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Hypokinesia; Parkinson Disease; Basal Ganglia Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Brain Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ann-Charlot Rughaven, M.Sc.

CONTACT

+4521123531; ann-charlot.rughaven@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will receive sham patterned repetitive transcranial magnetic stimulation (prTMS) by flipping the coil upside down. This will still provide similar sensory experience as an active stimulation that the patients will not distinguish between. Bradykinesia assessment is filmed during the visit and an experienced rater is unaware of a treatment condition of the patient.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Prof., DMSc

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 9, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After study completion
• Access Criteria: Anonymized data, reasonable request

Locations

DK (1)