Cognitive Dysfunction in Parkinson's Disease

NCT02346708 | Completed Results

• 2 other identifiers: 13-27241K02NS080885-01A1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about the brain function related to thinking problems in individuals with Parkinson's disease.

Conditions

Parkinson's Disease

Keywords

Parkinson's; TMS; Kluger

Outcome Measures

Primary Outcomes (1)

• Change in Magnetoencephalography (MEG) Connectivity Measures

  Our MEG outcome will be a change in small-worldness, global efficiency, nodal efficiency and degree distribution pre-TMS to immediately post-TMS treatment.

  2 weeks

Secondary Outcomes (1)

• Post-TMS Change From Baseline in Cognitive Scores

  2 weeks

Study Arms (2)

Real TMS

EXPERIMENTAL

TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease.52, 123 Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.

Device: Real TMS

Sham TMS

SHAM COMPARATOR

Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.

Device: Sham TMS

Interventions

Real TMS DEVICE

real treatment

Also known as: Transcranial Magnetic Stimulation

Real TMS

Sham TMS DEVICE

placebo treatment

Sham TMS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable PD (using United Kingdom Brain Bank criteria)
• Diagnosis of mild cognitive impairment
• No unstable medical condition

You may not qualify if:

• Features suggestive of other causes of Parkinsonism or other neurological disorders
• Prior deep brain stimulation (DBS) or ablation surgery
• Evidence for active depression or Hospital Anxiety and Depression Scale (HADS) score greater than or equal to 11
• Motor symptoms expected to interfere with scanning (e.g. sever tremor)
• Contraindications to TMS, MEG, or MRI such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold
• Implanted electronic devices or metal

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

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.

Results Point of Contact

• Title: Isabelle Buard, PhD
• Organization: University of Colorado Denver - Anschutz Medical Campus

Isabelle.Buard@cuanschutz.edu

(303)724-5973

Study Officials

• Benzi M Kluger, MD, MS

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: February 9, 2021
• Results First Posted: December 9, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)