rTMS as an Intervention for Levodopa-induced Dyskinesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2027-05-01

Brief Summary

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The proposed study investigates the use of repetitive transcranial magnetic stimulation (rTMS) as a treatment for levodopa-induced dyskinesia (LID) in Parkinson's Disease (PD). Specifically, the study aims to determine whether patterned stimulation of the pre-supplementary motor area (pre-SMA) can delay the onset of LID after levodopa intake and reduce LID severity in PD patients. This study will provide critical insights into potential targets for rTMS treatment, optimal rTMS parameters, and the mechanisms underlying LID in Parkinson's disease.

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Detailed Description

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Long-term use of levodopa in Parkinson's Disease (PD) often leads to motor complications, such as Levodopa-Induced Dyskinesia, which significantly impacts patients' daily lives. Various brain regions have been targeted for treatment with Transcranial Magnetic Stimulation (TMS), including the supplementary motor area (SMA), primary motor cortex, cerebellum, and prefrontal cortex. Specifically, targeting the pre-SMA with 1-Hz rTMS has been shown to delay and reduce dyskinesia severity in PD patients following levodopa administration. These findings suggest that the pre-supplementary motor area is a promising target for brain stimulation therapy, as it plays a causal role in the pathophysiology of peak-of-dose dyskinesia.

The current study aims to build on previous research by optimizing the stimulation intensity and location based on individual neuroanatomy and simulated electric fields. Additionally, the study will explore the impact of rTMS delivered in short high-frequency bursts, differing from the single rTMS pulses used in previous studies. In the context of LID, Deep Brain Stimulation (DBS) typically targets the subthalamic nucleus (STN) using gamma frequencies (40-200 Hz, most commonly 130 Hz). Drawing from this principle, the study posits that delivering rTMS bursts at gamma frequencies to the pre-SMA will effectively mitigate LID symptoms. Moreover, evidence from cortical brain rhythm recordings highlights that beta frequencies (12-30 Hz), which are crucial for movement control and are disrupted in PD, may also hold therapeutic potential. Therefore, the study will investigate whether rTMS bursts at beta frequencies could similarly reduce LID symptoms. Given the absence of prior research directly comparing the effects of different burst frequencies on LID, the study will systematically apply two distinct burst frequencies, in separate patient groups, to determine which, if either, produces a meaningful reduction in LID symptoms.

Dyskinesia onset time and severity will be measured using the Unified Dyskinesia Rating Scale (UDysRS) and assessed by a clinician rater who is blinded to the treatment condition. The results will be compared between the active and sham stimulation conditions.

Conditions

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Dyskinesia, Drug-Induced Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study has a double-blinded crossover design. The research participants will, in two separate stimulation sessions, receive either real rTMS treatment or a sham-TMS stimulation. The session order (real rTMS first or sham first) will be randomised between research participants. The research participant will be blinded to which treatment (real or sham) they receive at any session. There will be two sequential groups of patients. First group will receive gamma burst rTMS stimulation and sham and the other group will receive beta burst rTMS and sham.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will receive sham rTMS by flipping the coil upside down. This will still provide similar sensory experience as an active stimulation that the patients will not distinguish between. Dyskinesia assessment is filmed during the visit and an experienced rater is unaware of a treatment condition of the patient.

Study Groups

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Gamma burst rTMS

Real stimulation with 4 pulses at the frequency of 130Hz repeating at 1 Hz will be delivered on the pre-SMA using the active side of the coil for 30 minutes

Group Type ACTIVE_COMPARATOR

active TMS

Intervention Type DEVICE

Transcranial magnetic stimulation using MagVenture XP Orange Stimulator using active side of MagVenture Cool-B70 coil

Sham gamma burts rTMS

Sham stimulation with 4 pulses at the frequency of 130Hz repeating at 1Hz will be delivered on the pre-SMA with a non-active side of the coil for 30 minutes

Group Type SHAM_COMPARATOR

sham TMS

Intervention Type DEVICE

Sham transcranial magnetic stimulation using MagVenture XP Orange Stimulator, flipping the active side of the MagVenture Cool-B70 coil

Beta burst rTMS

Real stimulation with 4 pulses at the frequency of 20Hz repeating at 1 Hz be delivered on the pre-SMA using the active side of the coil for 30 minutes

Group Type ACTIVE_COMPARATOR

active TMS

Intervention Type DEVICE

Transcranial magnetic stimulation using MagVenture XP Orange Stimulator using active side of MagVenture Cool-B70 coil

Sham beta burst rTMS

Sham stimulation with 4 pulses at the frequency of 20Hz repeating at 1Hz will be delivered on the pre-SMA with a non-active side of the coil for 30 minutes

Group Type SHAM_COMPARATOR

sham TMS

Intervention Type DEVICE

Sham transcranial magnetic stimulation using MagVenture XP Orange Stimulator, flipping the active side of the MagVenture Cool-B70 coil

Interventions

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active TMS

Transcranial magnetic stimulation using MagVenture XP Orange Stimulator using active side of MagVenture Cool-B70 coil

Intervention Type DEVICE

sham TMS

Sham transcranial magnetic stimulation using MagVenture XP Orange Stimulator, flipping the active side of the MagVenture Cool-B70 coil

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinically established or probable PD
* Clinical Diagnostic Criteria for Parkinson's Disease
* Peak-of-dose levodopa-induced dyskinesia.
* Stable antiparkinsonian medicine for at least four weeks.
* Signed informed consent.

Exclusion Criteria

* Psychiatric disorders.
* Usage of antipsychotic medication, Donepezil, and GABAergic medications (such as pregabalin and gabapentin).
* Regular usage of benzodiazepines and opioids (more than once per week).
* History of neurological disease other than Parkinson's disease.
* History of epilepsy/conditions associated with increased risk to seizure-induction through TMS.
* Close relatives suffering from epilepsy/conditions associated with increased risk to seizure-induction through TMS.
* Contraindications for MRI scan
* Female participants of childbearing age must not be pregnant and that they 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No