rTMS as an Intervention for Levodopa-induced Dyskinesia
NCT Number: NCT06570824
Acronym: ADAPT-LIDI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dyskinesia, Drug-Induced|Parkinson Disease
Interventions: DEVICE: active TMS|DEVICE: sham TMS
Sponsor: Danish Research Centre for Magnetic Resonance
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2027-05-01
Locations: DRCMR, Hvidovre, 2650, Denmark

Summary:
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.

Primary Outcome Measures: Unified Dyskinesia Rating Scale (UDysRS), UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia.The UDysRS total score ranges from 0 to 104 with a lower score indicating less dyskinesia., Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick|Dyskinesia onset time, The onset time of dyskinesia in minutes after levodopa administration, Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick
Secondary Outcome Measures: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in active stimulation compared to sham. The total scores range from 0 (good health) to 132 (poor health)., Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick
Other Outcome Measures: TMS 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., Immediately after the TMS intervention (sham and active)|Transcranial evoked potentials (TEPs), Change in cortical excitability pre-post stimulation and OFF-ON states after levodopa administration, Before and immediately after the TMS intervention (sham and active), up to 20 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick|Event related potentials (ERPs), Dynamics of EEG during a Go/Nogo task: movement related potentials, spectral features, Immediately after taking 150 % of normal morning levodopa dose as Madopar Quick|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., Baseline, 4-8 weeks after inclusion|Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire, 27-item self-administered questionnaire that is used for capturing both static and fluctuating non-motor symptoms in PD. Possible score for the NoMoFA ranges from 0 to 81 points, with higher scores implying a higher severity and frequency of nonmotor symptoms., Baseline, 4-8 weeks after inclusion|CANTAB battery, Measures of response inhibition, spatial planning and working memory and reaction time, Baseline, 4-8 weeks after inclusion|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., Baseline, 4-8 weeks after inclusion|The World Health Organization Quality of Life (WHOQOL), General quality of life assessment as a part of patient reported outcome assessment. The possible score ranges in each case from 0 to 100 points. Higher scores indicate better quality of life., Baseline, 4-8 weeks after inclusion|Movement dynamics, Duration of dyskinesia per day in minutes, OFF/ON periods per day in minutes, Continuous up to 8 weeks after inclusion