Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration

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Brief Title

Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration

Official Title

Noninvasive Cortical Stimulation (rTMS) for Motor and Non-Motor Features of Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBD)

Brief Summary

      Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal
      1. Therefore, there is an urgent need to find alternative therapies to treat atypical
      parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive
      tool that modulates cortical excitability with minimal discomfort and holds therapeutic
      promise in treating neurological and psychiatric disorders.

      The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear
      Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and
      functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and
      hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and
      linked with non-motor symptoms such as depression and apathy. In this proposal, we
      characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose
      that high-frequency and low-frequency rTMS directed over separate motor and prefrontal
      cortical targets of each network may show specific and selective beneficial effects on motor
      vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome
      measures include timed finger tapping tasks. Quantitative cognitive outcome measures comprise
      a visual analogue scale (VAS).

      If successful, this pilot study will provide proof of principle data to suggest potential
      benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to support
      future PSP/CBGD studies that include the use of rTMS to investigate the pathophysiology of
      motor and non-motor features of PSP and CBGD patients.
    

Detailed Description

      Background: Drug therapy of atypical parkinsonism is generally ineffective or minimal, and
      novel therapy approaches for atypical parkinsonian disorders are needed. Repetitive
      transcranial magnetic stimulation (rTMS) is a noninvasive tool that modulates cortical
      excitability and holds promise in treating neurological/psychiatric disorders. The 'motor'
      basal ganglia-cortical circuit is implicated in parkinsonian akinesia and hypokinesia; a
      'prefrontal' circuit is implicated in working memory (WM) and mood regulation, possibly
      linked to depression and apathy.

      Hypothesis: Motor deficits in Progressive Supranuclear Palsy (PSP) and Corticobasal
      Ganglionic Degeneration (CBGD) are associated with a dysfunctional motor network; emotional
      deficits in PSP/CBGD are associated with a dysfunctional prefrontal network. We hypothesize
      that high-frequency and low-frequency rTMS over cortical targets will selectively and
      specifically improve tasks and symptoms relevant to that target in PSP and CBGD patients,
      respectively.

      Aims: To contrast cortical excitability characteristics and motor and emotional function
      between PSP and CBGD patients. To determine selective and specific beneficial rTMS effects
      over primary motor (M1) and dorsolateral prefrontal (DLPFC) cortex on cortical excitability
      characteristics and motor and emotional function in PSP and CBGD patients.

      Design: Ten individuals with PSP and ten with CBGD will participate in a within-subject
      cross-sectional design. Motor outcome measures include a timed finger tapping task at
      comfortable and maximal speed. Quantitative cognitive outcome measures comprise a visual
      analogue scale of mood states (VAS). After a first baseline visit, PSP patients will receive
      high-frequency 5 Hz rTMS in two separate visits to two site conditions (left DLPFC vs. the
      more affected side of M1) across subjects with two within-session task conditions (motor vs.
      cognitive). They will also receive sham stimulation in a separate visit. These three
      stimulation visits will be randomized. CBGD patients will receive the same treatment with the
      only difference that they will receive low-frequency 1 Hz rTMS instead.

      Relevance: If successful, we will demonstrate a double-dissociation and causal functional
      significance between rTMS modulation of M1 in motor tasks and DLPFC in emotional function in
      PSP Vs. CBGD. Exploratory aims will be conducted. Sufficient data and experience for future
      PSP/CBGD intervention studies will help identify candidate TMS parameters that are optimal
      for given symptoms.
    


Study Type

Observational


Primary Outcome

Cortical excitability (CE) measures expressed in motor evoked potentials (MEP)

Secondary Outcome

 visual analog scale (VAS)

Condition

Progressive Supranuclear Palsy


Study Arms / Comparison Groups

 PSP patients
Description:  People that have been clinically diagnosed with atypical parkinsonism, i.e., PSP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

30

Start Date

October 2008

Completion Date

February 2012

Primary Completion Date

December 2011

Eligibility Criteria

        Inclusion Criteria:

        If you are an adult with PSP or CBGD:

        1. Must be in good physical health.

        If you are neurologically healthy volunteers:

        1. Must be older than 35 years

        Exclusion Criteria:

          1. Must have no implanted metal. Dental fillings are acceptable.

          2. Must have no personal seizure or 1st degree relative with history of seizures

          3. Must not take any medication that lowers seizure threshold.
      

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Allan Wu, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01174771

Organization ID

UCaliforniaLA

Secondary IDs

CurePSP

Responsible Party

Principal Investigator

Study Sponsor

University of California, Los Angeles


Study Sponsor

Allan Wu, M.D., Principal Investigator, UCLA Neurology


Verification Date

May 2014