Cognitive Dysfunction in Parkinson's Disease
NCT02346708, Not applicable, Completed, University of Colorado, Denver; results first posted 2020-12-09
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Dysfunction in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT02346708 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 49 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Colorado, Denver | ClinicalTrials.gov |
| Conditions | Parkinson's Disease | ClinicalTrials.gov |
| Interventions | Real TMS, Sham TMS | ClinicalTrials.gov |
| First posted | 2015-01-27 | ClinicalTrials.gov |
| Last updated | 2021-02-09 | ClinicalTrials.gov |
| Results first posted | 2020-12-09 | ClinicalTrials.gov |
| Limitations and caveats | Our specialized MEG data analyst working on the Primary outcome has encountered a Covid-related family emergency, which has delayed the analysis process. | ClinicalTrials.gov |
Registered outcomes 2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Magnetoencephalography (MEG) Connectivity Measures | 2 weeks | Our MEG outcome will be a change in small-worldness, global efficiency, nodal efficiency and degree distribution pre-TMS to immediately post-TMS treatment. | ClinicalTrials.gov |
| Secondary | Post-TMS Change From Baseline in Cognitive Scores | 2 weeks | Our behavioral outcome will be a change in the scores of the following tests: Mattis Dementia Rating Scale: Higher raw scores = better cognitive status, ranging from 0 to 144. Normative data in healthy subjects range from 137 to 144. Trail Making Test Trails B: average score is 75 seconds; deficient score is \> 273 seconds. Delis-Kaplan Executive Function System (DKEFS) - Verbal Fluency Test. Higher score = higher ability in language processing. Scales scores vary from 0 min to N/A max (no concrete maximum). DKEFS - Stroop Interference Test measures inhibitory control and cognitive flexibility. Performance is measured by completion time. No min or max value for this test. Test should be discontinued after 90 sec. For those, higher scores = higher abilities: California Verbal Learning Test (declarative memory, scale 0 to 80), Boston Naming Test (language, scale 0 to 60), Brief Test of Attention and Judgment of Line Orientation (scale 0 to 30) | ClinicalTrials.gov |
Outcomes 2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Magnetoencephalography (MEG) Connectivity Measures | 2 weeks | No data displayed because Outcome Measure has zero total analyzed. No participants were analyzed for this outcome measure. | ClinicalTrials.gov | ||
| SECONDARY | Post-TMS Change From Baseline in Cognitive Scores | 2 weeks | Scores on a scale | MEAN | ClinicalTrials.gov |
Results by group 12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Mattis Dementia Rating Scale (MDRS) at 2 weeks minus score on the MDRS at baseline | -1.4 | Standard Deviation 4.55 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Mattis Dementia Rating Scale (MDRS) at 2 weeks minus score on the MDRS at baseline | 0 | Standard Deviation 5.55 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Verbal fluency at 2 weeks minus score on the Verbal fluency at baseline | 0.3 | Standard Deviation 11.35 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Verbal fluency at 2 weeks minus score on the Verbal fluency at baseline | 1 | Standard Deviation 15.7 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Stroop Interference at 2 weeks minus score on the Stroop Interference at baseline | -9.1 | Standard Deviation 18.55 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Stroop Interference at 2 weeks minus score on the Stroop Interference at baseline | -2.9 | Standard Deviation 18.85 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Brief Test of Attention (BTA) at 2 weeks minus score on the BTA at baseline | -0.1 | Standard Deviation 4 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Brief Test of Attention (BTA) at 2 weeks minus score on the BTA at baseline | 0.6 | Standard Deviation 4.15 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Boston Naming Test (BNT) at 2 weeks minus score on the BNT at baseline | 0.2 | Standard Deviation 5.95 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Boston Naming Test (BNT) at 2 weeks minus score on the BNT at baseline | 1.4 | Standard Deviation 2.25 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Real TMS | Score on the Judgment of Line Orientation (JLO) at 2 weeks minus score on the JLO at baseline | 0.9 | Standard Deviation 4.7 | Scores on a scale | ClinicalTrials.gov |
| Post-TMS Change From Baseline in Cognitive Scores | Sham TMS | Score on the Judgment of Line Orientation (JLO) at 2 weeks minus score on the JLO at baseline | 1 | Standard Deviation 4.2 | Scores on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Real TMS | 24 | ClinicalTrials.gov | |
| Overall Study | STARTED | Sham TMS | 25 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Real TMS | 22 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Sham TMS | 24 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Real TMS | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Sham TMS | 1 | ClinicalTrials.gov |
Adverse events 18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | vasovagal syncope | Blood and lymphatic system disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | vasovagal syncope | Blood and lymphatic system disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| other | local pain | Skin and subcutaneous tissue disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | local pain | Skin and subcutaneous tissue disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| other | hallucinations | Psychiatric disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | hallucinations | Psychiatric disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| other | motor problems | Nervous system disorders | Real TMS | 0 | 22 | 0 | ClinicalTrials.gov |
| other | motor problems | Nervous system disorders | Sham TMS | 1 | 24 | 1 | ClinicalTrials.gov |
| other | mild blurry vision | Eye disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | mild blurry vision | Eye disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| other | confusion | Nervous system disorders | Real TMS | 0 | 22 | 0 | ClinicalTrials.gov |
| other | confusion | Nervous system disorders | Sham TMS | 1 | 24 | 1 | ClinicalTrials.gov |
| other | burst vein in eye | Vascular disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | burst vein in eye | Vascular disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| other | mild flu | Infections and infestations | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| other | mild flu | Infections and infestations | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
| serious | Hospitalization | Renal and urinary disorders | Real TMS | 1 | 22 | 1 | ClinicalTrials.gov |
| serious | Hospitalization | Renal and urinary disorders | Sham TMS | 0 | 24 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Real TMS | 0 | 22 | ClinicalTrials.gov |
| Total, all-cause mortality | Sham TMS | 0 | 24 | ClinicalTrials.gov |
| Total, other adverse events | Real TMS | 6 | 22 | ClinicalTrials.gov |
| Total, other adverse events | Sham TMS | 1 | 24 | ClinicalTrials.gov |
| Total, serious adverse events | Real TMS | 1 | 22 | ClinicalTrials.gov |
| Total, serious adverse events | Sham TMS | 0 | 24 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| K02NS080885 | Intrinsic Cortical Networks and Cognitive Dysfunction in Parkinson's Disease | KLUGER, BENZI M | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2013 to 2017 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Real TMS vs Sham TMS: deaths from any cause | Trial comparisons |
| Real TMS vs Sham TMS: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Line Angle Matching | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)