NCT06840145Completed
Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Bilateral M1-iTBS
Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Intermittent Theta-burst Stimulation Over the Bilateral Primary Motor Area: A Randomized, Double-blind, Sham-controlled, Crossover Trial Study
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
Intermittent theta-burst stimulation (iTBS) is a promising therapeutic option for Parkinson's disease patients. A study involving 24 patients will assess its effectiveness in alleviating clinical deficits. Patients will undergo 5 sessions of iTBS over the bilateral M1 and a 3-month washout period. Motor evaluation, neurocognitive assessment, serum biomarkers of neurodegeneration and neuroplasticity, and structural and functional MRI evaluations will be conducted at follow-up visits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 2 Sept 2023
- Start date
- 1 Jun 2022
- Primary completion date
- 12 Feb 2024
- Lead sponsor
- Instituto de investigación e innovación biomédica de Cádiz
- Diseases
- Parkinson disease
- NCT number
- NCT06840145
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 1 Jun 2022 to the primary completion date, 12 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received amantadine within the previous 60 days
- Any sign of atypical parkinsonism, neurological comorbidities, or history of cranioencephalic traumatism or epilepsy or any other contraindication for receiving neurostimulation with TMS (e.g., intracranial magnetic implant, cardiac pacemaker)
Other illness
- Presence of a serious systemic disease
- Presence of severe or moderate cognitive impairment comparable to dementia, as revealed by an MMP score of ≤ 24
- Any incapacitating psychiatric or other clinical condition that might affect the correct performance of this protocol, such as any dystonia and/or dyskinesia
Other
- Lack of a PD diagnosis that meets the UK PDSBB diagnostic criteria
Who the study is looking for
- Diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank diagnostic criteria (UK PDSBB) diagnostic criteria
- Disease duration of at least 5 years to reduce the risk of including levodopa-responsive atypical Parkinsonism patients;
- Disease symptomatology in the ON medication state at a H\&Y scale of II-III;
- Clinical and therapeutic stability in the last 2 months previous to the recruitment period; and
- Aged 45-75 years.
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.