Parkinson's Clinical Trial
— KL2Official title:
Cognitive Dysfunction in Parkinson's Disease
NCT number | NCT02468804 |
Other study ID # | 10-0771 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | November 2016 |
Verified date | July 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We hypothesize that reductions in gamma activity are a key mechanism underlying cognitive dysfunction in PD and that interventions to increase gamma activity will improve cognition.
Status | Completed |
Enrollment | 107 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 90 Years |
Eligibility | Inclusion Criteria: - We will recruit 60 PD patients through the University Colorado Hospital (UCH) Movement Disorders Clinic diagnosed with probable PD using United Kingdom (UK) Brain Bank Criteria. - PD patients will be of mild to moderate severity based on the Hohn and Yahr scale (score of 3 or less in on medication state) and be on a stable dose of PD medications. - Clinical severity will also be assessed using the Unified Parkinson Disease Rating Scale. - We do not anticipate recruitment to be difficult as UCH Movement clinics see over 800 PD patients annually, the majority of whom are stage 3 or less. - Controls will be approximately matched for age and gender as a group and recruited through clinic (spouses) and advertisements in the community. Exclusion Criteria: - Subjects will be excluded if they have significant depression (Beck Depression Inventory33 > 14) - Dementia (Mini Mental State Examination34 < 26 or Frontal Assessment Battery35 < 14) - Other neurological or psychiatric illness - Significant history of head injury, significant systemic medical diseases (e.g. liver failure, kidney failure, poorly controlled diabetes) - Deep Brain Stimulation (DBS) - Cognitive enhancing medications (e.g. stimulants or acetylcholinesterase inhibitors) or contraindications to either TMS or MRI (pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy or on medications known to lower seizure threshold). |
Country | Name | City | State |
---|---|---|---|
United States | UC Denver Building 534 | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in Error Rates on the NBack Task Between Real and Sham Stimulation Trials | The primary cognitive outcome will be the error rates on the N-back task measured before and after real or sham TMS as a measure of working memory.
A negative number indicates that error rate was higher (working memory skills were worse) in the sham than the real condition. A positive number indicates lower error rates (better working memory skills) in the sham vs real stimulation. |
Change immediately after a single session TMS (pre will be done 1 week prior) |
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