NCT00955032

Brief Summary

The purpose of this research study is to attempt to treat apathy in Parkinson's disease (PD) using high-frequency repetitive transcranial magnetic stimulation (rTMS) of the brain and to investigate the patterns of brain activation that may be involved in apathy. It is hypothesized that high-frequency rTMS of the left mid-dorsolateral frontal cortex will improve apathy in PD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration 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

April 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2012

Completed
Last Updated

April 26, 2013

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

August 5, 2009

Results QC Date

December 5, 2011

Last Update Submit

April 19, 2013

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseApathyrTMSRepetitive transcranial magnetic stimulationDepression

Outcome Measures

Primary Outcomes (1)

  • Apathy Evaluation Scale (AES)

    The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.

    Pre-Tx; 10 days post tx

Secondary Outcomes (3)

  • Lille Apathy Rating Scale (LARS)

    Pre-Tx; 10 days post-tx

  • Beck Depression Inventory-Second Edition (BDI-II)

    Pre-Tx; 10 days post-tx

  • Hamilton Depression Rating Scale (HAM-D)

    Pre-Tx; 10 days post-tx

Study Arms (2)

High-Frequency Repetitive Transcranial Magentic Stimulation

EXPERIMENTAL

High-Frequency repetitive transcranial magnetic stimulation patients randomized to this treatment will receive left prefrontal rTMS, each treatment will consist of 2000 stimuli (50 - 8-second trains of 40 stimuli at 5 Hz). We will administer rTMS trains every 30 seconds for 25 minutes. Stimulus intensity for the first and second trains will be 80 and 90% of Motor Evoked Potential (MEP) threshold, respectively.

Device: High-Frequency Repetitive Transcranial Magnetic Stimulation

Sham Repetitive Transcranial Magentic Stimulation

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation patients randomized to receive the sham rTMS will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using Magstim Placebo 70 mm figure-of-8 shaped coils which produce discharge noise and vibration similar to a real 70 mm coil without stimulating the cerebral cortex. However, in addition to obvious coil discharge noise, rTMS also causes electrical stimulation of the scalp. We will simulate this experience by attaching surface electrodes underneath the sham coil and in contact with the scalp.

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

High-Frequency Repetitive Transcranial Magnetic StimulationDEVICE

In patients randomized to receive left prefrontal rTMS, each treatment will consist of 2000 stimuli (50 - 8-second trains of 40 stimuli at 5 Hz). We will administer rTMS trains every 30 seconds for 25 minutes. Stimulus intensity for the first and second trains will be 80 and 90% of MEP threshold, respectively.

Also known as: rTMS Treatment
High-Frequency Repetitive Transcranial Magentic Stimulation
Sham Repetitive Transcranial Magnetic StimulationDEVICE

Patients randomized to receive sham rTMS will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using Magstim Placebo 70 mm figure-of-8 shaped coils which produce discharge noise and vibration similar to a real 70 mm coil without stimulating the cerebral cortex. However, in addition to obvious coil discharge noise, rTMS also causes electrical stimulation of the scalp. We will simulate this experience by attaching surface electrodes underneath the sham coil and in contact with the scalp.

Also known as: Sham Treatment
Sham Repetitive Transcranial Magentic Stimulation

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
  • age 30 or over; and
  • on stable medications for at least 30 days.

You may not qualify if:

  • features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
  • history of deep brain stimulation or ablation surgery, significant headaches, epilepsy or seizure disorder, mass brain lesions, or major head trauma leading to loss of consciousness of any length;
  • family (1st degree relatives) history of epilepsy;
  • evidence for dementia;
  • presence of contraindications for functional magnetic resonance imaging (fMRI);
  • history of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year;
  • need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
  • unstable medical condition such as diabetes, cardiac disease, hypertension;
  • pregnancy; and
  • colorblindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseLethargyDepression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Limitations and Caveats

Due to recruiting difficulties, only 24 participants completed study participation. Despite this, the investigators still had significant power to examine effects of interest.

Results Point of Contact

Title
Dr. Hubert Fernandez
Organization
Center for Neurological Restoration Cleveland Clinic
fernandez@neurology.ufl.edu
(216) 445-1108

Study Officials

  • Hubert H Fernandez, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

April 1, 2007

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

April 26, 2013

Results First Posted

February 20, 2012

Record last verified: 2012-09

Locations

US(1)