NCT05509842Toborzás még nem indult
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
High-dose Accelerated Theta Burst Stimulation to Restore PD-induced Motor Network Dysconnectivity
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for Parkinson disease is the use of drugs that provide dopamine replacement therapy (DRT). However, as the disease progresses there are prominent DRT-resistant features of Parkinson disease that are a major source of disability. These include cognitive (attention, memory) impairments and gait disorders such as freezing and falls. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, holds promise for the study and treatment of motor and cognitive deficits in persons with Parkinson's. To date, there are no conclusive results regarding an optimal rTMS protocol for recovery of motor and cognitive deficits in Parkinson's disease. This study is designed to promote clinical rehabilitation neuroscience research, and aims to improve rehabilitation in persons with Parkinson's with freezing of gait. This work will evaluate the use of a new accelerated, high dose, non-invasive brain stimulation method for treatment of freezing of gait in PD and will test how applying targeted accelerated stimulation to the brain improves gait disturbance due to PD.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2022. aug. 17.
- Kezdés
- 2027. szept. 1.
- Elsődleges befejezés
- 2028. ápr. 1.
- Fő szponzor
- University of Michigan
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT05509842
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 20
- 2027. szept. 1. és az elsődleges befejezés (2028. ápr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Evidence of a stroke or mass lesion on prior structural brain imaging (CT or MRI)
- Have cochlear hearing implants
- Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors that facilitate neuroplasticity
- Have metal anywhere in the head that could increase a subjects risk of serious injury (not including braces, dental fillings, etc.):
- deep brain or vagus nerve stimulator
- aneurysm clips or coils
- stents in neck or brain
- implanted stimulators
- electrodes to monitor brain activity
- metallic implants in eyes or ears
- shrapnel or bullet fragments in or near the head
- facial tattoos with metallic or magnetic-sensitive ink
- other metal devices or objects implanted in or near the head,
Más betegség
- The presence of other neurologic disease or neurologic findings on examination
- Have any of the below conditions that would put a subject at increased risk of having a seizure:
- a personal or family history of seizure/epilepsy
- taking prescription drugs that lower the threshold for seizures
- recent history of excessive alcohol consumption
- history of alcohol addiction/dependence
- recent history of recreational drug use
- history of drug addiction/dependence
- Have been diagnosed with any of the following:
- A stroke, brain hemorrhage, brain tumor, encephalitis, or multiple sclerosis
- Alzheimer's disease
- attention deficit disorder, schizophrenia, or manic depressive (bipolar) disorder
- normal pressure hydrocephalus or increased intra-cranial pressure
- diabetes requiring insulin treatment
- any serious heart disorder or liver disease
- Metallic medical implants (i.e. pacemaker), foreign objects in body, non-removable body-piercings 7. Pregnancy 8. Additional exclusion criteria related to TMS: g. Metal in the cranium (mouth excluded) h. Cardiac pacemaker i. Implanted medication pump j. Implanted deep brain stimulator or vagus nerve stimulator k. Intracardiac lines l. Serious heart disease m. Increased intracranial pressure n. History of seizures o. Epileptogenic medication p. Cochlear implants q. Recent extended air travel resulting in jetlag or other sleep deprived state
Életkor
- Are younger than 45 or older than 90 years old
Egyéb
- Depression: Geriatric Depression Scale (GDS) score >11
- Non-English speaker
- Are pregnant, suspect pregnancy or are attempting to become pregnant
- Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
- Have non removable body piercings or have foreign objects in body
Kiket keres a vizsgálat
- Parkinson disease (PD) with PD diagnosis based on the recent Movement Disorder Society criteria
- PD subjects >45 years and <90 will be studied
- H\&Y2-3 (early PD) subjects will be recruited
- English speaker
- Able to provide written consent prior to admission
Életkor a regiszterben: 45 év – 90 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 |
|---|---|---|---|
| University of Michigan | Ann Arbor | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.