NCT07399496Toboroz
Accelerated rTMS for Apathy in Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 5.
Rövid összefoglaló (regiszter, angolul)
This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at one week, two weeks, and four weeks post-treatment. Fifteen participants with PD without clinically significant apathy will act as a comparison group and will undergo imaging (EEG and MRI), assessments, and questionnaires at baseline. Caregivers for each participant will complete questionnaires regarding their co-participant's symptoms as well as answer questions about their experience as a caregiver.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. jan. 7.
- Kezdés
- 2026. szept. 9.
- Elsődleges befejezés
- 2027. szept. 9.
- Fő szponzor
- Medical University of South Carolina
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07399496
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2026. szept. 9. és az elsődleges befejezés (2027. szept. 9.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year
- Co-participant/Caregiver
Más betegség
- Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
- Individuals with a history of seizure(s).
- Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (<21)
- Neuropsychiatric disorder diagnosis
- Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (<21)
- Co-participant/Caregiver
Egyéb
- Claustrophobia or inability to lie supine in the scanner for an extended period of time
- barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
- Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings.
- Pregnancy
- Unable to engage with study procedures in which co-participant input is needed.
- PD Control Group
- Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
- Claustrophobia or inability to lie supine in the scanner for an extended period of time
- Contraindications to MRI safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings
- Uncorrected visual or hearing impairments, as indicated by self-report
- Pregnancy
- Unable to engage with study procedures in which co-participant input is needed.
Kiket keres a vizsgálat
- 45-85 years of age
- Diagnosis of PD based on UK Brain Bank diagnostic criteria
- Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37
- Stable on Parkinsons medications (not expected to change through the course of the treatment)
- Ability to have a co-participant/caregiver who meets criteria below.
- 18 years of age or older
- Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's apathy and everyday functioning.
- Age matched to participants in the PD Apathy group (45 to 85 years of age)
- Diagnosis of PD based on UK Brain Bank diagnostic criteria [17]
- Stable on Parkinsons medications (not expected to change through the course of the study)
- 18 years of age or older 4) Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's mood and everyday functioning.
A regiszterben nem jelölt feltételek
- PD Apathy Participant
Életkor a regiszterben: 45 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Medical University of South Carolina | Charleston | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.