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Clinical and Research Reports
Published Online: 12 February 2024

Harnessing Placebo Effects for the Treatment of Functional Cognitive Disorder: A Feasibility Pilot Study

Matthew J. Burke, M.D. [email protected], Davide Cappon, Ph.D., David L. Perez, M.D., M.M.Sc., Alvaro Pascual-Leone, M.D., Ph.D., and Emiliano Santarnecchi, Ph.D.Authors Info & Affiliations
Publication: The Journal of Neuropsychiatry and Clinical Neurosciences
Volume 36, Number 3
https://doi.org/10.1176/appi.neuropsych.20230118
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Abstract

Objective:

Limited research has directly investigated whether and how placebo effects can be harnessed for the treatment of functional neurological disorder (FND), despite a long-standing and controversial history of interest in this area.

Methods:

A small exploratory study was conducted with adults with a cognitive subtype of FND recruited from a single cognitive neurology center in the United States. Participants were given the expectation of receiving cranial stimulation that could benefit their memory symptoms; however, the intervention was sham transcranial magnetic stimulation (placebo). Outcomes included measures of short-term memory testing, subjective memory rating, and state anxiety before and after stimulation. After the study, the true objective and rationale for investigating placebo effects were explained in a scripted debriefing session. Acceptability of the study design and qualitative feedback were collected. Institutional ethics approval and signed consent were obtained.

Results:

Three patients (female, N=2; male, N=1; average age=57 years) were recruited. Outcome data were analyzed descriptively at the patient level. Trends of improvement in subjective memory rating, but not objective cognitive test scores, and decreases in state anxiety were observed. After the debriefing session, all patients found the study design to be acceptable (ratings of 70%, 90%, and 100%), and two of the three patients believed that withholding mechanistic information about the intervention was needed to leverage placebo effects as treatment.

Conclusions:

In the first study to prospectively investigate the feasibility of harnessing placebo effects for the treatment of FND, promising preliminary findings were obtained, and methods and resources for use in larger future studies are offered.

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Supplementary Material

File (appi.neuropsych.20230118.ds001.pdf)

Information & Authors

Information

Published In

Go to The Journal of Neuropsychiatry and Clinical Neurosciences
Go to The Journal of Neuropsychiatry and Clinical Neurosciences
The Journal of Neuropsychiatry and Clinical Neurosciences
Volume 36 • Number 3 • Summer 2024
Pages: 214 - 219
PubMed: 38343313

History

Received: 20 July 2023
Revision received: 10 October 2023
Revision received: 8 November 2023
Accepted: 9 November 2023
Published online: 12 February 2024
Published in print: Summer 2024

Keywords

  1. Functional Neurological Disorder
  2. Placebo Effects
  3. Rehabilitation (Neuropsychiatric)
  4. Sham Stimulation
  5. Somatoform Disorders
  6. Transcranial Magnetic Stimulation

Authors

Affiliations

Matthew J. Burke, M.D. [email protected]
Neuropsychiatry Program, Department of Psychiatry, and Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Burke); Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto (Burke); Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology (Burke, Cappon, Santarnecchi) and Program in Placebo Studies (Burke), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Center for Memory Health, Hebrew SeniorLife, Boston (Cappon, Pascual-Leone); Department of Neurology, Harvard Medical School, Boston (Cappon, Pascual-Leone, Santarnecchi); Departments of Neurology and Psychiatry (Perez) and Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging (Santarnecchi), Massachusetts General Hospital and Harvard Medical School, Boston; Guttmann Brain Health Institute, Barcelona, Spain (Pascual-Leone).
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Davide Cappon, Ph.D.
Neuropsychiatry Program, Department of Psychiatry, and Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Burke); Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto (Burke); Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology (Burke, Cappon, Santarnecchi) and Program in Placebo Studies (Burke), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Center for Memory Health, Hebrew SeniorLife, Boston (Cappon, Pascual-Leone); Department of Neurology, Harvard Medical School, Boston (Cappon, Pascual-Leone, Santarnecchi); Departments of Neurology and Psychiatry (Perez) and Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging (Santarnecchi), Massachusetts General Hospital and Harvard Medical School, Boston; Guttmann Brain Health Institute, Barcelona, Spain (Pascual-Leone).
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David L. Perez, M.D., M.M.Sc.
Neuropsychiatry Program, Department of Psychiatry, and Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Burke); Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto (Burke); Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology (Burke, Cappon, Santarnecchi) and Program in Placebo Studies (Burke), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Center for Memory Health, Hebrew SeniorLife, Boston (Cappon, Pascual-Leone); Department of Neurology, Harvard Medical School, Boston (Cappon, Pascual-Leone, Santarnecchi); Departments of Neurology and Psychiatry (Perez) and Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging (Santarnecchi), Massachusetts General Hospital and Harvard Medical School, Boston; Guttmann Brain Health Institute, Barcelona, Spain (Pascual-Leone).
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Alvaro Pascual-Leone, M.D., Ph.D.
Neuropsychiatry Program, Department of Psychiatry, and Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Burke); Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto (Burke); Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology (Burke, Cappon, Santarnecchi) and Program in Placebo Studies (Burke), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Center for Memory Health, Hebrew SeniorLife, Boston (Cappon, Pascual-Leone); Department of Neurology, Harvard Medical School, Boston (Cappon, Pascual-Leone, Santarnecchi); Departments of Neurology and Psychiatry (Perez) and Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging (Santarnecchi), Massachusetts General Hospital and Harvard Medical School, Boston; Guttmann Brain Health Institute, Barcelona, Spain (Pascual-Leone).
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Emiliano Santarnecchi, Ph.D.
Neuropsychiatry Program, Department of Psychiatry, and Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Burke); Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto (Burke); Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology (Burke, Cappon, Santarnecchi) and Program in Placebo Studies (Burke), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston; Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Center for Memory Health, Hebrew SeniorLife, Boston (Cappon, Pascual-Leone); Department of Neurology, Harvard Medical School, Boston (Cappon, Pascual-Leone, Santarnecchi); Departments of Neurology and Psychiatry (Perez) and Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging (Santarnecchi), Massachusetts General Hospital and Harvard Medical School, Boston; Guttmann Brain Health Institute, Barcelona, Spain (Pascual-Leone).
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Notes

Send correspondence to Dr. Burke ([email protected]).

Author Contributions

Drs. Pascual-Leone and Santarnecchi share senior authorship.

Competing Interests

Dr. Perez has received honoraria for continuing medical education lectures; he has received royalties from Springer Nature; he has served on the editorial boards of Brain and Behavior, Epilepsy & Behavior, and the Journal of Neuropsychiatry and Clinical Neurosciences; and he has received funding from NIH and the Sidney R. Baer, Jr. Foundation. Dr. Pascual-Leone has served on the scientific advisory boards of Hearts Radiant, Magstim, MedRhythms, Neuroelectrics, Skin2Neuron, and TetraNeuron; he is co-founder of TI Solutions and cofounder and chief medical officer of Linus Health; and he is listed as an inventor on several issued and pending patents on the real-time integration of transcranial magnetic stimulation with electroencephalography and MRI, on applications of noninvasive brain stimulation in various neurological disorders, and on digital biomarkers of cognition and digital assessments for early diagnosis of dementia. The other authors report no financial relationships with commercial interests.

Funding Information

Supported by the Liu Fu Yu Charity Foundation and the Sidney R. Baer, Jr. Foundation. Supported in part by the Brain and Behavior Research Foundation (grant 30772 to Dr. Cappon), the BrightFocus Foundation (Dr. Pascual-Leone), and NIH (grant R01AG076708 to Dr. Cappon and grants R01AG076708, R01AG059089, R03AG072233, and P01AG031720 to Dr. Pascual-Leone).

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