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clinical-tms-clinic/SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md

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Standard Operating Procedure: TMS Treatment Protocol

Document ID SOP-TMS-001
Title Transcranial Magnetic Stimulation Treatment Protocol
Revision 1.0
Effective Date [DATE]
Author [AUTHOR]
Approved By [APPROVER]
Department TMS Clinic

1. Purpose

To establish standardized procedures for the safe and effective administration of Transcranial Magnetic Stimulation (TMS) therapy in accordance with FDA clearances, manufacturer guidelines, and clinical best practices.

2. Scope

This procedure applies to all TMS treatments including:

  • Repetitive TMS (rTMS) for Major Depressive Disorder
  • rTMS for Obsessive-Compulsive Disorder
  • Intermittent Theta Burst Stimulation (iTBS)
  • Other FDA-cleared or investigational protocols

3. Responsibilities

3.1 TMS Technician/Operator

  • Position patient and equipment
  • Determine motor threshold
  • Administer treatment per prescription
  • Monitor patient during treatment
  • Document treatment parameters

3.2 Prescribing Physician

  • Evaluate patient eligibility
  • Prescribe treatment protocol
  • Review progress and adjust treatment
  • Manage adverse events
  • Provide medical oversight

3.3 Clinical Coordinator

  • Schedule treatments
  • Track treatment compliance
  • Coordinate patient assessments
  • Maintain equipment logs

4. Definitions

Term Definition
MT Motor Threshold - minimum intensity to produce MEP
MEP Motor Evoked Potential - observable motor response
rTMS Repetitive Transcranial Magnetic Stimulation
iTBS Intermittent Theta Burst Stimulation
DLPFC Dorsolateral Prefrontal Cortex - common target for depression

5. Equipment and Materials

  • TMS device (FDA-cleared)
  • Treatment coil (figure-8 or appropriate for indication)
  • Positioning chair or table
  • Ear protection (ear plugs)
  • Treatment cap or head marking system
  • Motor threshold determination tools
  • Emergency equipment (as per emergency SOP)

6. Procedure

6.1 Pre-Treatment Assessment

6.1.1 Initial Evaluation (First Treatment)

  1. Verify Prescription

    • Diagnosis confirmed
    • Treatment protocol specified
    • Contraindications reviewed
    • Informed consent on file

  2. Safety Screening Confirm absence of contraindications:

    • No ferromagnetic metal in head/neck
    • No implanted devices (pacemaker, cochlear implant, DBS)
    • No history of seizures (unless per protocol)
    • No unstable medical conditions
    • Current medications reviewed for seizure threshold effects
    • Pregnancy test negative (if applicable)

  3. Baseline Assessments

    • PHQ-9 or HAM-D (depression)
    • Y-BOCS (OCD, if applicable)
    • Vital signs
    • Cognitive baseline if indicated

6.1.2 Daily Pre-Treatment Check

Before each session:

  • Patient identity verified
  • Assess for new contraindications
  • Confirm adequate sleep (>4 hours)
  • Confirm no alcohol/illicit substances
  • Confirm no significant medication changes
  • Assess for current illness
  • Review previous session tolerance

6.2 Motor Threshold Determination

Required at:

  • First treatment session
  • Any significant change in medications affecting neural excitability
  • If treatment efficacy changes significantly
  • Per physician order

Procedure:

  1. Position patient comfortably
  2. Place coil over motor cortex (M1) contralateral to dominant hand
  3. Begin at 30-40% machine output
  4. Deliver single pulses at 10-second intervals
  5. Observe for thumb/finger movement (APB)
  6. Increase intensity by 5% increments
  7. Record lowest intensity producing 5 MEPs in 10 trials
  8. Document MT and method used
MT Parameter Value
Date
Resting Motor Threshold (%)
Target Muscle
Number of Trials
Determined By

6.3 Treatment Coil Positioning

6.3.1 Left DLPFC Targeting (Standard Depression Protocol)

5-cm Rule Method:

  1. Identify motor hotspot (from MT determination)
  2. Measure 5 cm anteriorly along scalp surface
  3. Mark position on treatment cap
  4. Verify coil angle (45° to midline)

Neuronavigation Method (if available):

  1. Register patient to MRI
  2. Identify target coordinates
  3. Position coil using navigation system
  4. Document coordinates and trajectory

6.3.2 Alternative Targets

  • Right DLPFC (low-frequency protocol)
  • Supplementary Motor Area (OCD)
  • Other per protocol specification

6.4 Treatment Administration

  1. Patient Preparation

    • Seat in treatment chair
    • Provide ear protection
    • Position head comfortably
    • Instruct patient on what to expect

  2. Equipment Setup

    • Power on device and perform calibration
    • Select prescribed protocol
    • Set treatment parameters:
      Parameter Value
      Frequency (Hz)
      Intensity (% MT)
      Pulses per train
      Inter-train interval
      Total pulses
      Duration

  3. Treatment Delivery

    • Position coil at marked location
    • Maintain consistent coil contact
    • Begin treatment delivery
    • Monitor patient continuously
    • Pause if patient reports concerning symptoms

  4. Patient Monitoring During Treatment Observe for:

    • Facial twitching (may indicate coil drift)
    • Signs of distress
    • Seizure warning signs
    • Excessive discomfort

6.5 Standard Treatment Protocols

Major Depressive Disorder - Standard rTMS

Parameter Left DLPFC
Frequency 10 Hz
Intensity 120% MT
Train duration 4 seconds
Inter-train interval 26 seconds
Trains per session 75
Total pulses 3,000
Session duration ~37.5 minutes
Total sessions 30-36

Major Depressive Disorder - iTBS

Parameter Left DLPFC
Pattern 50 Hz bursts at 5 Hz
Intensity 120% MT
Bursts per train 10 (30 pulses)
Inter-train interval 8 seconds
Total pulses 600
Session duration ~3 minutes
Total sessions 30-36

6.6 Post-Treatment

  1. Immediate Assessment

    • Ask about side effects
    • Assess for headache, scalp pain
    • Evaluate mental status
    • Confirm safe to leave

  2. Documentation Complete FRM-TMS-001 Treatment Log:

    • Date and session number
    • Treatment parameters used
    • Coil position
    • Patient tolerance
    • Any adverse effects
    • Operator signature

  3. Patient Instructions

    • Mild headache/scalp discomfort common
    • OTC analgesics acceptable
    • Report severe/persistent symptoms
    • Confirm next appointment

6.7 Adverse Event Management

Event Severity Action
Scalp discomfort Mild Adjust position, OTC analgesic
Headache Mild-Moderate OTC analgesic, reduce intensity if persistent
Syncope Moderate Stop treatment, lie patient down, assess vitals
Seizure Severe Stop treatment, protect patient, follow seizure protocol

Seizure Response:

  1. Stop stimulation immediately
  2. Note time
  3. Protect patient from injury
  4. Do not restrain
  5. Call for help / activate emergency protocol
  6. Monitor airway and breathing
  7. Time seizure duration
  8. Notify physician immediately
  9. Complete incident report

7. Outcome Monitoring

Assessment Timing Tool
Depression severity Weekly PHQ-9 or HAM-D
OCD severity (if applicable) Weekly Y-BOCS
Side effects Each session TMS side effect checklist
Treatment response Sessions 10, 20, 30 Physician evaluation
Remission assessment End of acute course Full clinical evaluation

8. Documentation

  • FRM-TMS-001 TMS Treatment Log
  • FRM-TMS-002 Motor Threshold Record
  • FRM-TMS-003 Side Effect Checklist
  • Outcome assessment forms
  • Equipment maintenance logs

9. References

  • FDA clearance documentation
  • Manufacturer operating manual
  • Clinical practice guidelines (APA, CANMAT)
  • Peer-reviewed TMS literature

Revision History

Rev Date Description Author
1.0 [DATE] Initial release [AUTHOR]
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