prTMS as an Intervention for Bradykinesia in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDanish Research Centre for Magnetic Resonance
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Active patterned repetitive transcranial magnetic stimulation (prTMS)
DeviceTranscranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot using active side of MagVenture Cool-B65 coil
Sham patterned repetitive transcranial magnetic stimulation (prTMS)
DeviceSham transcranial magnetic stimulation (TMS) using Axilum Robotics TMS-Cobot, flipping the active side of the MagVenture Cool-B65 coil.
Treatment groups
27 Participants
are divided into 3 treatment groupsGroup A: Active patterned repetitive transcranial magnetic stimulation (prTMS) before a movementActive comparator 1 intervention
Group B: Active patterned repetitive transcranial magnetic stimulation (prTMS) between a movementExperimental treatment 1 intervention
Group C: Sham patterned repetitive transcranial magnetic stimulation (prTMS) before a movementSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)2
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,
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)Secondary outcomes
1
Transcranial evoked potentials (TEPs)
Change in cortical excitability pre-post stimulation over the SMA
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)2
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).
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)3
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
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)4
Motor Evoked Potentials (MEPs)
Change in cortical excitability pre-post stimulation measured bilateral from the first dorsal interosseous and tibialis anterior
Time frame
Immediately before and after each session of patterned repetitive transcranial magnetic stimulation (prTMS)Other outcomes
1
Transcranial Magnetic Stimulation Adverse Events and Associated Sensations Questionnaire (TMSens_Q)
Questionnaire for assessing any side effects and sensations associated with TMS stimulation, including the assessment of masking (sham or active treatment) of participants. Each item is rated on a 5-point Likert scale from 0 (no sensation) to 4 (severe sensation), with higher scores indicating worse outcomes.
Time frame
Immediately after the patterned repetitive transcranial magnetic stimulation (prTMS) intervention2
Non-Motor Symptoms Scale for Parkinson's Disease (NMSS)
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The scores on the NMSS range from 0 to 360, with higher scores implying a higher severity and frequency of nonmotor symptoms.
Time frame
Baseline, 4-8 weeks after inclusion3
CANTAB battery
Measures of response inhibition, spatial planning and working memory and reaction time
Time frame
Baseline, 4-8 weeks after inclusion4
The Parkinson's Disease Questionnaire (PDQ-39)
39 item self-administered questionnaire that assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
Time frame
Baseline, 4-8 weeks after inclusionSponsors and contacts
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Source ClinicalTrials.gov