NCT02468804

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

3.3 years

First QC Date

October 18, 2013

Results QC Date

April 6, 2020

Last Update Submit

July 6, 2021

Conditions

Parkinson's

Keywords

Parkinson'sNon-parkinsons

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (4)

Parkinson's Disease Subjects, (rTMS)

EXPERIMENTAL

The PD subjects will be randomized, and on a separate day receive a course of either real (rTMS) or sham TMS. Twenty minutes after this treatment subjects will again perform the same working memory task (at 9am to control for fatigue and diurnal effects) while having MEG data recorded

Device: rTMS

Control Subjects (rTMS)

EXPERIMENTAL

The control subjects will be randomized, and on a separate day receive a course of either real (rTMS) or sham TMS. Twenty minutes after this treatment subjects will again perform the same working memory task (at 9am to control for fatigue and diurnal effects) while having MEG data recorded

Device: rTMS

Parkinson's Disease Subjects, (sTMS)

SHAM COMPARATOR

The PD subjects will be randomized, and on a separate day receive a course of either real (rTMS) or sham TMS. Twenty minutes after this treatment subjects will again perform the same working memory task (at 9am to control for fatigue and diurnal effects) while having MEG data recorded

Device: Sham TMS

Control Subjects (sTMS)

SHAM COMPARATOR

The control subjects will be randomized, and on a separate day receive a course of either real (rTMS) or sham TMS. Twenty minutes after this treatment subjects will again perform the same working memory task (at 9am to control for fatigue and diurnal effects) while having MEG data recorded

Device: Sham TMS

Interventions

rTMSDEVICE

TMS: Repetitive TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Stimulator (Magstim, Jali Medical US distributors, Woburn, MA). Repetitive pulses will be delivered to the right and left pre-frontal cortex (Brodman area 46) using a frameless stereotactic navigation system and the subject's MRI in Brainsight software. Stimuli will be delivered at 20 Hz at 90% of the subjects 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. The same TMS parameters as active stimulation but with the coil held at 90° to the scalp to induce similar somatic sensations and noise as in the active group with minimal direct brain effects.

Also known as: Repetitive Transcranial Magnetic Stimulation
Control Subjects (rTMS)Parkinson's Disease Subjects, (rTMS)
Sham TMSDEVICE

Sham TMS will be administered with a Magstim sham coil with electrodes attached to mimic the sounds and sensation of real TMS. The site and frequency of stimulation will be identical to the real TMS described above.

Control Subjects (sTMS)Parkinson's Disease Subjects, (sTMS)

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Denver Building 534

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Isabelle Buard, PhD
Organization
University of Colorado Denver
Isabelle.Buard@cuanschutz.edu
(303)472-5973

Study Officials

  • Benzi Kluger, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

June 11, 2015

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 27, 2021

Results First Posted

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

In Progress

Locations

US(1)